Director, International Regulatory Strategy

Role Purpose & Context

Role Summary

The Director, International Regulatory Strategy, is here to set our multi-year global regulatory agenda, which directly impacts our ability to launch new products and expand into new countries. You'll be sitting right at the intersection of our business unit's commercial ambitions and the ever-changing landscape of global health authority requirements. Your job is to translate complex, often ambiguous, international regulations into clear, actionable strategies that our product development, sales, and quality teams can actually follow. When you get this right, we launch products faster, avoid costly recalls, and protect our reputation. When it goes wrong, we could face significant fines, market withdrawals, or even criminal charges – frankly, the stakes are incredibly high. The biggest challenge? Balancing aggressive growth targets with prudent risk management, especially when regulations are still being written or interpreted differently across borders. The reward, though? You'll genuinely shape the future direction of our business, seeing your strategic vision come to life in markets all over the world, knowing you've kept us safe and successful.

Reporting Structure

• Reports to: VP / Chief Regulatory & Compliance Officer
• Direct reports: Roughly 25-100+ individuals, including managers and senior specialists across different regions.
• Matrix relationships: Head of Global Regulatory Affairs, VP Regulatory Compliance (Strategy), Senior Director, Regulatory Affairs & Policy,

Key Stakeholders

Internal:

• Business Unit General Managers (for strategic alignment and market access)
• Head of R&D and Product Development (for early-stage regulatory input)
• Legal Counsel (for interpretation of complex laws and risk mitigation)
• Commercial and Sales Leadership (for market entry and product claims)
• Quality Assurance Director (for QMS integration and audit readiness)
• Manufacturing and Supply Chain VPs (for operational compliance)

External:

• Major Health Authorities (e.g., FDA, EMA, MHRA, PMDA, NMPA)
• Notified Bodies (for CE marking and conformity assessments)
• Industry Associations (for lobbying and standard setting)
• External Legal and Regulatory Consultants (for specialist advice)
• Investors and Board Members (for reporting on risk and market access)

Organisational Impact

Scope: Your decisions directly influence the company's market access, product launch timelines, and overall risk profile. You're essentially the gatekeeper for global market entry, meaning you can make or break a product's success. Get it right, and we open up new revenue streams; get it wrong, and we could face significant reputational damage and financial penalties. It's a big job with big consequences.

Performance Metrics

Quantitative Metrics

1. Metric: New Market Entry Success Rate
2. Desc: The percentage of targeted new international markets where we successfully gain regulatory approval and launch products within the planned timeframe.
3. Target: Achieve >80% success rate for strategic market entries.
4. Freq: Annually, reviewed quarterly.
5. Example: In 2024, if we targeted 5 new markets and successfully launched in 4, that's an 80% success rate. This isn't just about getting approval, but doing it on time.
6. Metric: Time-to-Market Reduction (Regulatory Phase)
7. Desc: The average reduction in the regulatory approval phase for new product launches across key international markets, compared to historical averages or industry benchmarks.
8. Target: Reduce average regulatory time-to-market by 15-20% year-on-year.
9. Freq: Bi-annually.
10. Example: If a typical EU MDR submission took 18 months, your strategy should aim to get that down to 14-15 months through proactive engagement and submission quality.
11. Metric: Regulatory Audit & Inspection Outcome
12. Desc: The number and severity of findings from major health authority inspections (e.g., FDA 483s, EMA inspections, Notified Body audits) for your business unit.
13. Target: Zero 'Official Action Indicated' (OAI) or 'Major Critical' findings; aim for 'No Action Indicated' (NAI) or 'Minor Observations' in >95% of audits.
14. Freq: Per audit/inspection event.
15. Example: Successfully navigating an FDA inspection with only 1-2 minor observations (e.g., a documentation formatting issue), rather than a major finding that requires a CAPA.
16. Metric: Cost of Non-Compliance & Regulatory Fines
17. Desc: The total financial impact of regulatory penalties, fines, product recalls, or market withdrawals directly attributable to a failure in regulatory strategy or oversight.
18. Target: Zero significant regulatory fines or product recalls due to strategic compliance failures for your business unit.
19. Freq: Annually, with immediate reporting of any incidents.
20. Example: Avoiding a £5M fine from a national health authority because your team identified and remediated a compliance gap before it escalated to a market issue.

Qualitative Metrics

1. Metric: Strategic Influence & Counsel
2. Desc: How often senior leadership (GMs, VPs, C-suite) proactively seeks your input on strategic business decisions, market expansion plans, or product roadmap changes, rather than just informing you after the fact.
3. Evidence: You're regularly invited to executive strategy sessions; your opinions are genuinely considered and integrated into business plans; you're seen as a trusted advisor, not just a 'compliance checker'.
4. Metric: Team Leadership & Capability Building
5. Desc: The effectiveness of your leadership in developing a high-performing, strategically-minded regulatory team, capable of navigating complex global challenges and adapting to new regulations.
6. Evidence: High retention rates within your team; positive feedback in 360-degree reviews; demonstrable career progression for your direct reports; your team is recognised internally for its proactive, business-enabling approach.
7. Metric: External Reputation & Agency Relationships
8. Desc: The quality of our relationships with key health authorities and industry bodies, measured by constructive dialogue, successful pre-submission meetings, and our standing within the regulatory community.
9. Evidence: Positive feedback from agency contacts; our organisation is invited to participate in regulatory working groups; successful outcomes in scientific advice meetings; our reputation as a credible, transparent partner.
10. Metric: Proactive Risk Anticipation
11. Desc: Your ability to identify and communicate emerging regulatory risks or opportunities well in advance, allowing the business to adapt and plan strategically, rather than reactively.
12. Evidence: Regular, insightful briefings to leadership on future regulatory trends (e.g., new AI regulations, changes in environmental health standards); your team consistently flags potential issues 12-18 months out; business decisions are demonstrably altered based on your foresight.

Primary Traits

• Trait: Influential (Not just a rule-follower)
• Manifestation: You're the one who can persuade an engineering team that a more expensive, but more compliant, material is actually the right long-term move. You'll convince the marketing department to rephrase product claims to genuinely reduce regulatory risk, even if it means toning down the 'wow factor'. Honestly, you'll be arguing for a larger budget based on the very real cost of non-compliance, and you'll win those arguments.
• Benefit: This role isn't just about knowing the rules; it's about getting a complex, matrixed organisation of engineers, marketers, and operators to actually follow them. Often, this happens when it's inconvenient or costly for them. Without real influence, you're just a librarian of regulations nobody reads, and that's not what we need at this level. You need to drive change, not just report on it.
• Trait: Decisive (Under ambiguity)
• Manifestation: You'll be making the tough 'go/no-go' calls on a major submission when agency guidance is vague or contradictory. You're comfortable interpreting a brand-new regulation with no legal precedent and then creating a corporate policy based on your best judgment. Sometimes, you'll need to advise the CEO to pull a product from a market based on an evolving political or regulatory risk, even when it's a multi-million-pound decision.
• Benefit: Regulatory affairs rarely gives you perfect information. You simply must be comfortable making high-stakes decisions based on your best risk assessment and strategic judgment. The reality is, you'll be held accountable for the outcome, so sitting on the fence isn't an option. We need someone who can cut through the noise and make a call.
• Trait: Meticulously Precise (Verging on pedantic)
• Manifestation: You're the kind of person who spots that a date format is DD-MM-YYYY in one section of a 2,000-page submission and MM-DD-YYYY in another, and you'll fix it. You'll catch a subtle but critical difference between the EU and UK versions of the same regulation that others miss. You'll insist on exact, consistent terminology across all technical documentation, because you know it matters. Frankly, your attention to detail might seem a bit obsessive to some.
• Benefit: A single misplaced comma, an incorrect reference number, or an inconsistent data point in a major submission can easily lead to months of delays and millions in lost revenue. Precision isn't just a nice-to-have; it's the bedrock of our credibility with regulators. If they can't trust the small details, they won't trust the big picture, and that's a problem for the whole business.

Supporting Traits

• Trait: Resilient
• Desc: Truth is, you'll face rejection from agencies and plenty of pushback from internal teams who don't want to hear 'no'. The ability to absorb that, learn from it, and keep moving forward with a clear head is absolutely crucial here. You can't take things personally.
• Trait: Diplomatic
• Desc: You'll often be delivering bad news – like telling a product team their launch is delayed because of a compliance issue. You need to do this without alienating the very people you need to work with to fix the problem. It's a delicate balance of firmness and collaboration.
• Trait: Commercially Astute
• Desc: You can't just be a regulatory expert; you need to connect dense regulations to real business outcomes: revenue, market share, competitive advantage. You'll need to explain why compliance isn't just a cost, but an enabler of sustainable growth.

Primary Motivators

1. Motivator: Strategic Impact & Business Protection
2. Daily: You'll be driven by the knowledge that your decisions directly protect the company from massive fines or product recalls, and enable multi-million-pound market entries. Seeing a product successfully launch globally because of your team's strategy will be a huge win.
3. Motivator: Solving Complex, Ambiguous Problems
4. Daily: You thrive on wrestling with vague, contradictory international laws and figuring out a compliant, yet commercially viable, path forward. The harder the regulatory puzzle, the more engaged you'll be.
5. Motivator: Building & Leading High-Performing Teams
6. Daily: You get a real buzz from mentoring and developing your managers and specialists, seeing them grow into strategic regulatory experts themselves. You'll enjoy shaping the future talent of the compliance function.

Potential Demotivators

Honestly, this isn't a role for everyone. If you crave absolute certainty, you'll struggle. The goalposts move constantly, and you'll often be asked to make calls with incomplete information. If you need every piece of your work to be perfectly 'clean' or follow a predictable path, this might drive you mad.

Common Frustrations

1. The 'Last-Minute Checkbox': Being brought into a product development cycle at the very end, only to discover a fundamental design flaw that violates regulations and forces a costly, last-minute redesign. It's like being asked to fix a broken car after it's already crashed.
2. Sales Over-promising: The constant battle with the commercial team who sell features or promise delivery dates in new countries before you've even had a chance to assess the regulatory pathway. You'll feel like you're constantly reining them in.
3. Moving Goalposts: Spending two years developing a product to meet a specific regulation, only for the health authority to publish new 'guidance' three months before launch that changes all the requirements. It's incredibly frustrating.
4. The 'Department of No' Reputation: The internal perception of being a roadblock or a cost centre, when your actual function is to enable long-term, sustainable market access by preventing catastrophic compliance failures. It's a thankless job sometimes.
5. The Black Box Wait: Submitting a multi-million-pound product application and then waiting 6, 12, or even 24 months for a response from a government agency with zero visibility into the process or timeline. It tests your patience, big time.

What Role Doesn't Offer

1. Predictable, routine tasks: Every day brings new regulatory challenges and ambiguities.
2. Instant gratification: Regulatory approvals can take years, and strategic impact unfolds over multi-year horizons.
3. Complete control: You'll be influencing, not dictating, across many functions and external bodies.

ADHD Positives

1. The fast-paced, high-stakes nature of international regulatory strategy can be incredibly engaging for those with ADHD, offering constant novelty and intellectual stimulation.
2. Excellent ability to hyperfocus on complex regulatory documents or strategic problem-solving when a critical deadline looms.
3. Often brings innovative, 'outside the box' thinking to complex regulatory challenges, finding pathways others might miss.

ADHD Challenges and Accommodations

1. Managing multiple, long-term strategic initiatives and their associated documentation can be challenging; we can help with structured project management tools and executive assistants for administrative support.
2. Maintaining consistent, meticulous detail across thousands of pages of submissions requires robust systems; we use advanced GRC platforms and AI tools to reduce manual burden and offer flexible working arrangements to optimise focus.
3. Dealing with the 'black box wait' periods from agencies can be frustrating; we can provide opportunities to pivot to other high-impact strategic projects during these times.

Dyslexia Positives

1. Often possess strong spatial reasoning and pattern recognition, which is brilliant for spotting overarching trends in complex regulatory texts or identifying inconsistencies across different national regulations.
2. Excellent verbal communication skills for presenting complex strategies to leadership or negotiating with agencies, often simplifying intricate information effectively.
3. A 'big picture' strategic view that can cut through granular details to identify the most critical regulatory risks and opportunities.

Dyslexia Challenges and Accommodations

1. Reading and proofreading incredibly dense, lengthy regulatory documents can be taxing; we provide access to advanced text-to-speech software, AI-powered summarisation tools, and dedicated proofreading support.
2. Ensuring absolute precision in written submissions and policy documents requires careful review; we implement robust review processes, use grammar/spelling checkers (like Grammarly Business), and encourage verbal communication for initial drafts.
3. Organising vast amounts of textual information; we use highly visual collaboration platforms (like Confluence) and mind-mapping tools for strategic planning.

Autism Positives

1. Exceptional ability to deep-dive into complex regulatory frameworks, understanding intricate details and interconnections that others might overlook.
2. A strong adherence to rules and logical consistency, which is invaluable in interpreting and applying regulatory requirements rigorously.
3. Often brings a unique, objective perspective to strategic discussions, cutting through political noise to focus on facts and compliance.

Autism Challenges and Accommodations

1. Navigating complex, often unspoken, social dynamics in cross-functional leadership meetings can be difficult; we can provide clear agendas, pre-reads, and direct feedback channels.
2. Dealing with ambiguity and frequent changes in regulatory guidance can be unsettling; we strive for clear communication of strategic shifts and provide structured frameworks for risk assessment.
3. Sensory overload in open-plan office environments; we offer flexible working arrangements, noise-cancelling headphones, and access to quiet zones for focused work.

Key Responsibilities

Experience Levels Responsibilities

1. Level: Director, International Regulatory Strategy (Level 006)
2. Responsibilities: Define the multi-year international regulatory strategy for our entire business unit. This isn't just about reacting to changes; it's about proactively shaping our market access and product development roadmap (think 3-5 years out).
3. Accountable for all major regulatory submissions and approvals across your designated global regions. If a £50M product launch gets delayed in the EU, that's on your desk.
4. Build and lead a high-performing team of regulatory managers and specialists. You'll be coaching them, setting their strategic priorities, and making sure they're developing the skills we need for the future.
5. Serve as the primary interface with senior leadership (GMs, VPs, C-suite) on all critical regulatory matters. You'll be presenting complex risks and opportunities to them, often in board-level discussions.
6. Drive transformation in our regulatory processes and systems. We're talking about optimising how we do things globally, probably involving new tech and streamlining workflows across different countries.
7. Influence key external stakeholders, including major health authorities and industry bodies. You'll be representing our company's position, advocating for sensible regulations, and building those crucial relationships.
8. Oversee the regulatory due diligence for potential M&A activities, assessing the compliance risks and opportunities of acquiring new companies or product portfolios. This means digging deep into their regulatory skeletons.
9. Supervision: You'll operate with full strategic autonomy within your business unit. Supervision will be limited to monthly strategic alignment meetings with the VP / Chief Regulatory & Compliance Officer and quarterly objective reviews. You're expected to self-direct and proactively flag any major issues.
10. Decision: You'll have full authority within your domain: defining and owning the regulatory strategy for your business unit, allocating budgets up to £5M, making all hiring and firing decisions for your team, and approving major regulatory submissions. Any decisions impacting P&L above £10M or requiring M&A involvement will need alignment with the C-suite.
11. Success: Success here means consistently achieving our market entry targets, significantly reducing time-to-market for new products through proactive strategy, and maintaining an impeccable regulatory compliance record with zero critical audit findings or major fines. Ultimately, you'll be judged on how effectively you enable sustainable business growth while mitigating regulatory risk globally.

Decision-Making Authority

• Type: Regulatory Strategy Definition (Business Unit)
• Entry: Contributes data and analysis for specific tasks.
• Mid: Proposes solutions for routine strategic challenges.
• Senior: Leads development of strategy for a workstream, with Director input.
• Type: Budget Allocation (Regulatory Function)
• Entry: No budget authority.
• Mid: Manages small project budgets (up to £5K) with manager approval.
• Senior: Approves project-level spend up to £50K, consults Director on larger.
• Type: Major Regulatory Submission Approval
• Entry: Prepares components, requires full review and approval.
• Mid: Compiles and reviews routine submissions, requires manager sign-off.
• Senior: Leads complex submissions, recommends approval to Director.
• Type: M&A Due Diligence Recommendations
• Entry: N/A
• Mid: N/A
• Senior: Contributes regulatory risk assessment for specific product lines.

Competency Requirements

Foundation Skills (Transferable)

To truly excel as a Director of International Regulatory Strategy, you'll need a rock-solid set of foundational skills. These aren't just 'soft skills'; they're the bedrock that allows you to translate complex regulatory knowledge into strategic business outcomes, influence senior leaders, and build a high-performing team. Frankly, without these, even the deepest technical expertise won't get you far at this level.

• Category: Strategic Leadership & Vision
• Skills: Organisational Strategy: Ability to define and articulate a multi-year regulatory vision that directly supports the business unit's growth objectives and market access goals. This means thinking beyond current regulations to anticipate future trends.
• Decision Making Under Ambiguity: Consistently making high-stakes strategic decisions with incomplete or conflicting regulatory information, always balancing risk with commercial opportunity. You're the one who makes the call when there's no clear answer.
• Change Leadership: Driving significant organisational change to adapt to new regulatory landscapes or implement new compliance frameworks. This involves getting buy-in from reluctant teams and overcoming resistance.
• Talent Development & Mentorship: Building, coaching, and developing a team of regulatory managers and specialists. You're responsible for their growth, making sure we've got the right talent for tomorrow's challenges.
• Category: Influence & Communication
• Skills: Executive Communication: Articulating complex regulatory issues, risks, and strategic recommendations clearly and concisely to C-suite executives and board members. This isn't just about presenting data; it's about telling a compelling story.
• Negotiation & Persuasion: Successfully negotiating with health authorities, notified bodies, and internal stakeholders (e.g., R&D, Sales) to achieve compliant, yet commercially viable, outcomes. You'll need to win people over.
• Cross-functional Collaboration: Building strong, credible relationships with leaders across product, engineering, legal, quality, and commercial teams to ensure regulatory strategy is integrated from the outset, not an afterthought.
• External Representation: Acting as a credible and authoritative representative of the company to external regulatory bodies, industry associations, and public forums. Your words carry weight.
• Category: Problem Solving & Critical Thinking
• Skills: Complex Problem Solving: Tackling novel regulatory challenges where no clear precedent exists, designing innovative solutions that meet both compliance requirements and business needs. This often means charting new territory.
• Risk Management & Mitigation: Identifying, assessing, and proactively mitigating significant regulatory risks across multiple international markets. You're thinking about the 'what ifs' and putting plans in place.
• Analytical Acumen: Interpreting vast amounts of regulatory data, guidance documents, and scientific literature to extract key insights and inform strategic decisions. You're looking for patterns and implications.

Functional Skills (Role-Specific Technical)

Beyond the foundational leadership skills, you'll need deep, strategic expertise in the core functions of international regulatory affairs. This isn't about doing the day-to-day tasks anymore; it's about defining the 'how' and 'why' at a global level, ensuring our technical capabilities are always fit for purpose.

Technical Competencies

• Skill: Regulatory Pathway Assessment (Strategic)
• Desc: You'll be defining the global methodology for determining the most efficient and compliant regulatory pathway for entire product portfolios or new market entries. This means making high-level strategic calls on 510(k) vs. PMA, CE marking under MDR/IVDR, or novel routes in emerging markets, always with a view on speed and risk.
• Level: Expert
• Skill: Horizon Scanning & Impact Analysis (Enterprise-wide)
• Desc: You'll be accountable for establishing and continuously refining our proactive system for monitoring proposed regulations, lobbying efforts, and competitor submissions across all relevant jurisdictions. The goal is to forecast multi-year changes and quantify their potential operational and financial impact on the entire business, informing long-term R&D and commercial strategy.
• Level: Expert
• Skill: Gap Analysis & Remediation Planning (Strategic Oversight)
• Desc: You'll oversee the strategic framework for comparing existing product documentation, quality processes, and testing data against new or updated regulations. This includes approving major remediation project plans and ensuring resources are allocated effectively to close significant shortfalls across the business unit.
• Level: Expert
• Skill: Regulatory Agency Engagement (Executive Level)
• Desc: You'll be the primary executive interface for formal and informal communication with major health authorities (e.g., FDA, EMA, MHRA) on critical, high-stakes matters. This includes leading scientific advice meetings, negotiating responses to significant deficiency letters, and managing pre-submission strategies for groundbreaking products.
• Level: Expert
• Skill: Change Control Governance (Global Framework)
• Desc: You'll define and oversee the global framework for evaluating any change to a product, process, or supplier to determine if it requires a notification or a new submission to a regulatory body. This means ensuring consistency and efficiency across all regions and product lines, embedding compliance into our change management culture.
• Level: Expert
• Skill: Post-Market Surveillance (PMS) & Vigilance Reporting (Strategic Oversight)
• Desc: You'll be responsible for the strategic oversight of our global PMS system, ensuring robust monitoring of real-world product performance and timely, accurate incident reporting to regulatory authorities. This includes setting policy for risk assessments (HHEs) and ensuring compliance with all vigilance requirements, protecting both patients and our market position.
• Level: Expert

Digital Tools

• Tool: ServiceNow GRC / Veeva Vault (QualityDocs/Submissions)
• Level: Strategic
• Usage: Leading the strategic selection, implementation, and integration of GRC/QMS platforms across the business unit. You'll ensure these systems are architected to support global regulatory strategy and provide executive-level compliance oversight.
• Tool: Enhesa / RegScan / Thomson Reuters Regulatory Intelligence
• Level: Strategic
• Usage: Using intelligence data from these platforms to forecast long-term regulatory trends, identify emerging risks, and inform multi-year product roadmaps and market entry strategies. You're not just reading reports; you're using them to make big calls.
• Tool: Lorenz docuBridge / eCTD Express
• Level: Architect
• Usage: Setting the organisation's submission publishing standards, templates, and best practices. You'll evaluate and select new publishing tools, ensuring our e-submission capabilities are 'world-class' (and I mean that in a specific, provable way, not just fluff).
• Tool: MS Teams (with SharePoint integration) / Jira / Confluence
• Level: Strategic
• Usage: Mandating and standardising the use of these collaboration tools across cross-functional teams to ensure a single source of truth for all regulatory activities. You'll drive efficiency and transparency in regulatory project management at a global scale.
• Tool: Power BI / Tableau Server / Diligent Boards
• Level: Strategic
• Usage: Presenting interactive dashboards and board-level compliance reports to the C-suite and the Board of Directors. You'll use these tools to communicate complex regulatory performance, risks, and strategic initiatives in a clear, impactful way.

Industry Knowledge

• Area: Global Health Authority Structures & Processes
• Desc: Deep, nuanced understanding of how major health authorities (FDA, EMA, MHRA, PMDA, NMPA, etc.) operate, their decision-making processes, and their specific requirements for product approval and post-market surveillance. This isn't just theoretical; it's about knowing the practicalities and the politics.
• Area: Product Lifecycle Management (Regulatory Perspective)
• Desc: Comprehensive knowledge of regulatory requirements across the entire product lifecycle, from R&D and clinical trials through manufacturing, commercialisation, and eventual obsolescence. You'll understand how regulatory strategy needs to evolve at each stage.
• Area: Quality Management Systems (QMS) Integration
• Desc: Expertise in how QMS (e.g., ISO 13485, 21 CFR Part 820) integrates with regulatory compliance, ensuring that our quality processes support and enable our regulatory submissions and post-market obligations. You'll understand the interplay between quality and regulatory.
• Area: International Trade & Customs Compliance (Regulatory Interface)
• Desc: Understanding the regulatory interface with international trade laws, customs regulations, and import/export controls, particularly as they relate to regulated products. You'll need to know how these impact global supply chains and market access.

Regulatory Compliance Regulations

• Reg: EU Medical Device Regulation (MDR 2017/745) & IVDR (2017/746)
• Usage: Defining and overseeing the strategic compliance approach for all relevant products within the EU market, including clinical evaluation, technical documentation, UDI, EUDAMED requirements, and post-market surveillance. You'll be making calls on complex interpretations and remediation plans.
• Reg: US FDA Regulations (21 CFR Parts 800-898, 21 CFR Part 4)
• Usage: Leading the strategic approach to US market access, including 510(k), PMA, De Novo pathways, and combination product regulations. This involves high-level engagement with the FDA and ensuring robust pre-market and post-market compliance programs.
• Reg: UK Medical Device Regulations (UK MDR 2002, future UKCA regime)
• Usage: Developing and executing the strategy for UK market access, navigating the evolving post-Brexit regulatory landscape. This includes managing UKCA marking, MHRA registration, and understanding the divergences from EU regulations.
• Reg: APAC & LATAM Regional Regulatory Frameworks (e.g., TGA, HSA, MHLW, ANVISA)
• Usage: Overseeing the development of regional regulatory strategies for key APAC and LATAM markets, understanding the nuances of local requirements, submission processes, and agency engagement models. You'll be building out our capabilities in these growth regions.
• Reg: Global Data Privacy Regulations (e.g., GDPR, CCPA, HIPAA)
• Usage: Ensuring that regulatory strategies for product development and post-market activities are fully compliant with global data privacy laws, especially concerning patient data and clinical trial information. You'll work closely with Legal and IT security.

Essential Prerequisites

• Proven track record (16+ years) of progressive leadership roles in international regulatory affairs within a highly regulated industry (e.g., medical devices, pharmaceuticals, biotech). This isn't your first rodeo.
• Demonstrable experience in defining and executing global regulatory strategies that have led to successful product launches and market expansion.
• Significant experience managing and developing large, geographically dispersed regulatory teams, including managing managers.
• Expert-level knowledge of at least two major global regulatory frameworks (e.g., EU MDR/IVDR and US FDA regulations).
• A history of successful engagement and negotiation with senior health authority representatives.
• Experience in regulatory due diligence for M&A activities.

Career Pathway Context

To step into this Director role, you'll have already mastered the complexities of leading regulatory projects and managing portfolios (L3-L4) and will have spent significant time (5+ years) at a Senior Manager or Associate Director level (L5), developing and implementing global strategies for an entire business unit. This role is about taking that to the next level of strategic influence and accountability.

Qualifications & Credentials

Emerging Foundation Skills

• Skill: AI & Automation Strategy for Compliance
• Why: AI is already transforming how regulatory intelligence is gathered, how submissions are compiled, and how risks are identified. Leaders who can strategically integrate AI into their compliance frameworks will gain massive efficiencies and improve accuracy, while those who don't will fall behind. It's not just about using the tools, but defining *how* they're used to reshape the entire function.
• Concepts: [{'concept_name': 'Regulatory AI Governance', 'description': 'Establishing policies and frameworks for the ethical and compliant use of AI in regulatory activities, including data privacy, bias detection, and validation of AI-generated content.'}, {'concept_name': 'Process Re-engineering with AI', 'description': 'Redesigning core regulatory processes (e.g., submission generation, horizon scanning, CAPA management) to maximise the benefits of AI and automation, moving from manual to intelligent workflows.'}, {'concept_name': 'Vendor Selection & Integration', 'description': 'Evaluating and selecting AI-powered regulatory technology vendors, and overseeing the integration of these tools into existing GRC and QMS platforms.'}, {'concept_name': 'Predictive Compliance Modelling', 'description': 'Using AI and machine learning to predict future regulatory changes, potential non-compliance risks, or likely agency questions based on historical data and global trends.'}]
• Prepare: This quarter: Attend executive briefings on AI in highly regulated industries and identify 2-3 high-impact use cases for your business unit.
• Next 6 months: Lead a pilot project to implement an AI-powered regulatory intelligence tool or submission assistant within your team, measuring tangible productivity gains.
• Next 12 months: Develop a comprehensive AI strategy for your regulatory function, outlining governance, technology roadmap, and talent development needs.
• Ongoing: Engage with industry forums and thought leaders on AI in compliance to stay at the forefront of best practices and emerging risks.
• QuickWin: Start experimenting with LLMs (like ChatGPT or Claude) to draft summaries of complex regulatory documents or generate initial responses to common agency questions. It's a low-risk way to get familiar with the capabilities.
• Skill: Global Regulatory Harmonisation & Divergence Management
• Why: While there's a push for global harmonisation, we're also seeing increasing regulatory divergence (e.g., post-Brexit UK, China's unique pathways). As a Director, you'll need to strategically navigate these conflicting trends, finding efficiencies where possible while managing distinct national requirements. It's a constant balancing act.
• Concepts: [{'concept_name': 'Harmonisation Initiatives', 'description': 'Understanding and actively participating in global harmonisation efforts (e.g., ICH, GHTF, IMDRF) to influence future standards and reduce redundant efforts.'}, {'concept_name': 'Divergence Impact Assessment', 'description': 'Developing robust methodologies to assess the commercial and operational impact of new regulatory divergences between major markets, informing product design and market entry strategies.'}, {'concept_name': 'Modular Submission Strategies', 'description': 'Designing submission strategies that allow for modularity, enabling efficient adaptation to specific national requirements without redoing entire dossiers.'}, {'concept_name': 'Regulatory Agility Models', 'description': 'Implementing organisational structures and processes that allow for rapid adaptation to new national regulations or significant changes in existing ones.'}]
• Prepare: This quarter: Commission an internal report on the top 3 regulatory divergences impacting our business unit and present it to leadership with strategic recommendations.
• Next 6 months: Lead a cross-functional working group to develop a 'modular submission' template for a key product line, reducing time to market in diverse regions.
• Next 12 months: Actively participate in an industry working group focused on regulatory harmonisation or divergence, representing our company's interests.
• Ongoing: Regularly brief your team and senior leaders on emerging harmonisation opportunities and divergence risks, providing clear strategic guidance.
• QuickWin: Identify one product currently sold in both the EU and UK. Conduct a quick internal review to pinpoint the specific documentation differences and propose a streamlined approach for future updates.

Advancing Technical Skills

• Skill: Advanced GRC/QMS System Architecture
• Why: As our organisation grows and regulations become more complex, our GRC and QMS platforms need to be seamlessly integrated and highly scalable. You'll need to understand how to architect these systems to support enterprise-wide compliance, not just departmental needs.
• Concepts: [{'concept_name': 'Enterprise System Integration', 'description': 'Connecting GRC/QMS platforms with ERP (e.g., SAP S/4HANA), PLM, and CRM systems to create a unified data landscape for compliance.'}, {'concept_name': 'Data Governance for Compliance', 'description': 'Establishing robust data governance frameworks to ensure data quality, integrity, and traceability across all compliance-critical systems.'}, {'concept_name': 'Cloud-Native Compliance Solutions', 'description': 'Understanding the benefits and challenges of deploying GRC/QMS solutions in cloud environments, including security, scalability, and regulatory implications.'}]
• Prepare: This quarter: Work with IT and Quality leadership to review our current GRC/QMS architecture and identify key integration gaps.
• Next 6 months: Lead the development of a business case for a next-generation GRC/QMS platform or significant upgrade, focusing on strategic benefits.
• Next 12 months: Oversee the selection process for new GRC/QMS vendors, ensuring alignment with long-term regulatory strategy.
• Ongoing: Stay abreast of new developments in compliance technology and enterprise architecture trends.
• QuickWin: Map out the current data flow for a critical regulatory process (e.g., CAPA management) across all systems, identifying manual hand-offs and potential for automation.

Education Requirements

• Level: Minimum
• Req: A Bachelor's degree (or equivalent OFQUAL Level 6 qualification) in a relevant scientific, engineering, or legal discipline.
• Alts: We're open to candidates with exceptional, demonstrable experience (18+ years) in senior regulatory leadership roles, even without a degree, especially if coupled with relevant professional certifications.
• Level: Preferred
• Req: A Master's degree (OFQUAL Level 7) or PhD in Regulatory Affairs, Law, Biomedical Engineering, or a related field.
• Alts: An MBA or equivalent business qualification would also be highly advantageous, demonstrating commercial acumen.

Experience Requirements

You'll need a minimum of 16-20 years of progressive experience in international regulatory affairs, with at least 5-7 years in a senior leadership role (e.g., Senior Manager, Associate Director, or Director) managing global regulatory strategies and leading substantial teams. This isn't a role for someone who's just managed a small project; you need to have shaped entire business unit strategies and navigated complex, multi-country regulatory challenges.

Preferred Certifications

• Cert: Regulatory Affairs Certification (RAC)
• Prod: RAPS (Regulatory Affairs Professionals Society)
• Usage: Demonstrates a comprehensive understanding of regulatory requirements in the US and/or EU, and a commitment to professional development in the field.
• Cert: Certified Quality Auditor (CQA) / Certified Quality Manager (CQM)
• Prod: ASQ (American Society for Quality)
• Usage: Shows a deep understanding of quality management systems and auditing principles, which are critical for robust regulatory compliance and agency interactions.
• Cert: Project Management Professional (PMP)
• Prod: PMI (Project Management Institute)
• Usage: Highlights your ability to strategically manage complex, multi-year regulatory programmes and drive them to successful completion, especially important for cross-functional initiatives.

Recommended Activities

• Active participation in major industry associations (e.g., RAPS, MedTech Europe, AdvaMed) at a leadership level, influencing policy and networking with peers.
• Regular attendance and speaking engagements at international regulatory conferences and symposia, sharing our expertise and learning from others.
• Continuous learning on emerging technologies (e.g., AI, blockchain in supply chain) and their regulatory implications through specialised courses or workshops.
• Mentoring junior talent within the organisation and externally, contributing to the wider regulatory community.

Career Progression Pathways

Entry Paths to This Role

• Path: From Senior Manager, International Regulatory Strategy (L5)
• Time: 3-5 years at L5
• Path: From Head of Regulatory Affairs (Mid-Sized Company)
• Time: 4-6 years in a similar leadership role

Career Progression From This Role

• Pathway: VP / Chief Regulatory & Compliance Officer (L7)
• Time: 3-5 years as Director

Long Term Vision Potential Roles

• Title: Chief Regulatory & Compliance Officer (CRCO)
• Time: 5-10 years
• Title: VP, Global Market Access & Regulatory Affairs
• Time: 5-8 years
• Title: Distinguished Regulatory Strategist / Fellow
• Time: 5-10 years

How Zavmo Delivers This Role's Development

DISCOVER Phase: Skills Gap Analysis

Zavmo maps your current competencies against all requirements in this job description through conversational assessment. We evaluate your foundation skills (communication, strategic thinking), functional skills (CRM expertise, negotiation), and readiness for career progression.

Output: Personalised skills gap heat map showing strengths and priorities, estimated time to competency, neurodiversity accommodations.

DISCUSS Phase: Personalised Learning Pathway

Based on your DISCOVER results, Zavmo creates a personalised learning plan prioritised by impact: foundation skills first, then functional skills. We adapt to your learning style, pace, and neurodiversity needs (ADHD, dyslexia, autism).

Output: Week-by-week schedule, each module linked to specific job responsibilities, checkpoints and milestones.

DELIVER Phase: Conversational Learning

Learn through conversation, not boring modules. Zavmo uses 10 conversation types (Socratic dialogue, role-play, coaching, case studies) to build competence. Practice difficult QBR presentations, negotiate tough renewals, and handle churn conversations in a safe AI environment before facing real clients.

Example: "For 'Stakeholder Mapping', Zavmo will guide you through analysing a complex enterprise account, identifying key decision-makers, and building an engagement strategy."

DEMONSTRATE Phase: Competency Assessment

Zavmo automatically builds your evidence portfolio as you learn. Every conversation, practice scenario, and application example is captured and mapped to NOS performance criteria. When ready, your portfolio supports OFQUAL qualification claims and demonstrates competence to employers.

Output: Competency matrix, evidence portfolio (downloadable), qualification readiness, career progression score.