Vice President, Global Regulatory Affairs

Role Purpose & Context

Role Summary

The Vice President, Global Regulatory Affairs, is here to define and execute our entire worldwide regulatory strategy. Day-to-day, you'll be shaping our approach to new product development, managing our interactions with major health authorities like the FDA and EMA, and making sure we're ready for whatever new regulations pop up globally. You're the one who translates our company's ambitious R&D pipeline into a compliant, market-ready portfolio, ensuring our products get approved and stay approved across dozens of countries. If you do this well, our medicines reach patients faster, we avoid costly delays, and our reputation as a trusted, compliant company stays solid. Get it wrong, and we're looking at product withdrawals, massive fines, and a damaged public image. The challenge? It's a constant balancing act between commercial ambition, scientific innovation, and an ever-changing global regulatory landscape. The reward? You'll directly enable life-changing products to reach millions of people worldwide, knowing you've navigated the toughest regulatory hurdles to make it happen.

Reporting Structure

• Reports to: Chief Executive Officer (CEO)
• Direct reports: Typically 3-5 Director-level managers, who in turn manage teams of 10-20+ professionals.
• Matrix relationships: Chief Regulatory Officer, SVP, Global Regulatory Compliance, Head of Worldwide Regulatory Strategy,

Key Stakeholders

Internal:

• CEO and Executive Leadership Team
• Head of Research & Development
• Chief Commercial Officer
• Chief Medical Officer
• General Counsel
• Board of Directors (Audit & Risk Committees)

External:

• Major Global Health Authorities (e.g., FDA, EMA, MHRA, PMDA, NMPA)
• Industry Trade Associations (e.g., ABPI, EFPIA, PhRMA)
• Key Opinion Leaders (KOLs) and Patient Advocacy Groups
• External Legal Counsel and Regulatory Consultants
• Investors and Financial Analysts

Organisational Impact

Scope: This role is absolutely central to our ability to operate globally. You're directly responsible for securing and maintaining marketing authorisations for all our products, which means everything from initial drug approvals to managing post-market changes and ensuring our advertising is compliant. You'll shape our product development pathways, influence M&A decisions from a regulatory risk perspective, and ultimately, you're accountable for safeguarding our licence to operate and our reputation with regulators and the public. Your strategic decisions here have multi-year, multi-billion-pound implications for the entire enterprise.

Performance Metrics

Quantitative Metrics

1. Metric: Global Time-to-Approval (TTA) Reduction
2. Desc: Average time from submission to marketing authorisation for new products across key markets (e.g., US, EU, JP, China).
3. Target: Achieve a 15% reduction in average TTA for priority assets compared to industry benchmarks or prior year.
4. Freq: Annually, reviewed quarterly.
5. Example: If the industry average TTA for a novel oncology drug is 18 months, your goal might be to achieve 15.3 months (15% reduction) through strategic early engagement and robust dossier quality. This means getting a product to market 2.7 months faster, which is massive.
6. Metric: Regulatory Compliance Audit Findings
7. Desc: Number of critical or major findings related to regulatory affairs during internal audits or external health authority inspections.
8. Target: Zero critical findings; fewer than 2 major findings per year across all global regulatory functions.
9. Freq: Continuous monitoring, reported quarterly to the Board Risk Committee.
10. Example: Successfully pass an FDA pre-approval inspection (PAI) and an EMA routine GMP inspection with no critical observations and only one minor observation related to a documentation process.
11. Metric: Strategic Label Claim Achievement
12. Desc: Successful negotiation of commercially significant claims into product labels (e.g., broader indications, superior efficacy messaging, specific patient populations).
13. Target: Secure approval for at least 3 high-value, differentiated label claims annually across the portfolio.
14. Freq: Annually, tracked per product launch/variation.
15. Example: Successfully negotiate a 'first-in-class' claim for a new product's Summary of Product Characteristics (SmPC) in Europe, which significantly boosts its marketing potential compared to competitors.
16. Metric: Regulatory Risk Register Health
17. Desc: Proactive identification, assessment, and mitigation of enterprise-level regulatory risks, as tracked in the GRC platform.
18. Target: Maintain a 'green' status for 90% of identified high-impact regulatory risks, with clear mitigation plans and owners.
19. Freq: Quarterly review with the Executive Leadership Team and Board Risk Committee.
20. Example: Identify a potential new EU regulation on medical device software that could impact our digital health products two years before it comes into force, and implement a proactive strategy that results in full compliance without business disruption.

Qualitative Metrics

1. Metric: Executive & Board Confidence
2. Desc: The degree to which the CEO, Board, and other executive leaders trust your strategic counsel and rely on your function for critical business decisions.
3. Evidence: You're consistently brought into early-stage M&A discussions for regulatory due diligence. The CEO asks for your direct input on major R&D portfolio decisions. Board members actively seek your perspective on emerging global risks. You're seen as a proactive partner, not just a gatekeeper.
4. Metric: Global Regulatory Reputation
5. Desc: How our company is perceived by key health authorities and industry peers globally.
6. Evidence: Our company is invited to participate in pilot programmes for new regulatory pathways (e.g., FDA's Project Orbis). Health authorities are responsive and collaborative in pre-submission meetings. You're a sought-after speaker at major industry conferences, representing our company's thought leadership.
7. Metric: Talent Development & Succession Planning
8. Desc: The strength and depth of the regulatory team, including the development of future leaders.
9. Evidence: You have a clear succession plan for your direct reports. Your team members are regularly promoted into more senior roles, both within Regulatory Affairs and other functions. You're known for attracting and retaining top regulatory talent in a competitive market.
10. Metric: Cross-Functional Strategic Influence
11. Desc: Your ability to shape and influence the strategies of other critical functions (e.g., R&D, Commercial, Legal) to ensure regulatory success.
12. Evidence: R&D consistently incorporates regulatory input into early-stage clinical trial design. Commercial teams proactively consult Regulatory Affairs before developing new marketing campaigns. Legal relies on your team for interpreting complex regulatory guidance in litigation or policy debates. You're not just reacting; you're shaping.

Primary Traits

• Trait: The Enterprise Chess Master
• Manifestation: You're always thinking three moves ahead, anticipating how a new regulation in China might impact our EU strategy in two years. You connect the dots between a seemingly minor change in a US guidance document and its potential ripple effect on our global portfolio. You see the big picture, the interdependencies, and the long game—not just the next submission deadline.
• Benefit: At this level, you're not just managing regulations; you're shaping the company's future. A lack of foresight here can lead to missed market opportunities, costly reworks, or even product withdrawals. We need someone who can strategise at a global, multi-year level, identifying both risks and opportunities before anyone else.
• Trait: The Unflappable Diplomat
• Manifestation: You can calmly present bad news to the Board without causing panic, then turn around and negotiate a difficult label change with a demanding health authority reviewer, all while maintaining a professional and composed demeanour. When a major regulatory crisis hits, you're the steady hand, the voice of reason, and the one who can de-escalate tensions, both internally and externally.
• Benefit: This role is a pressure cooker. You're constantly dealing with high-stakes situations, often with conflicting internal and external demands. Losing your cool or failing to build trust with regulators or the executive team can have catastrophic consequences for our products and our reputation. Diplomacy and composure are non-negotiable.
• Trait: The Principled Navigator
• Manifestation: You'll stand firm on a regulatory principle even when it's commercially inconvenient, explaining the 'why' with clarity and conviction. You can find creative, compliant solutions to complex problems, always operating within the spirit and letter of the law, even when the path isn't obvious. You're the ethical compass, ensuring we never compromise patient safety or regulatory integrity for short-term gains.
• Benefit: Our licence to operate depends entirely on our integrity. This role requires someone who can navigate the grey areas of regulation without ever crossing the line. We need a leader who can guide the business to success compliantly, earning respect from both regulators and our internal teams for their unwavering principles.

Supporting Traits

• Trait: Exceptional Communicator
• Desc: Can distil complex regulatory science into clear, actionable insights for a CEO, or explain a nuanced policy position to a government official. You're as comfortable presenting to a board as you are explaining a regulatory pathway to a junior colleague.
• Trait: Strategic Influencer
• Desc: Able to persuade and align diverse, often strong-willed, executive stakeholders towards a common regulatory goal, even when it means challenging their initial assumptions or commercial desires.
• Trait: Business Acumen
• Desc: Understands the commercial implications of regulatory decisions, how they impact P&L, market access, and competitive positioning. You speak the language of business, not just regulation.
• Trait: Resilient Leader
• Desc: Bounces back from major regulatory setbacks (e.g., a Refuse-to-File, a difficult inspection outcome) and inspires their team to learn and adapt, maintaining morale and focus during challenging times.

Primary Motivators

1. Motivator: Safeguarding Patient Health
2. Daily: You're driven by the profound responsibility of ensuring every product we bring to market is safe and effective. This means relentlessly pushing for the highest standards, challenging shortcuts, and advocating for robust regulatory processes.
3. Motivator: Shaping Enterprise Strategy
4. Daily: You thrive on being at the executive table, influencing major company decisions, from M&A targets to R&D pipeline prioritisation, through a regulatory lens. You want to be a proactive architect of the business, not just a reactive gatekeeper.
5. Motivator: Global Impact & Influence
6. Daily: The idea of navigating complex international regulatory landscapes, influencing policy, and building relationships with global health authorities excites you. You want to see your strategic decisions enable products to reach patients in every corner of the world.

Potential Demotivators

Honestly, this role isn't for everyone. If you need constant, immediate gratification from seeing your work directly deployed, you might struggle. A lot of your impact is preventative—avoiding problems that never happen because of your foresight. You'll spend significant time in high-level strategic discussions where the outcomes aren't always clear-cut or quickly achieved. You'll also be the one who has to say 'no' to brilliant scientific ideas or ambitious commercial plans because they simply aren't compliant or carry too much risk. If you prefer a clear, linear path with predictable outcomes, or if you shy away from difficult conversations with powerful people, this won't be the right fit.

Common Frustrations

1. Having to tell the CEO that a major product launch will be delayed due to an unexpected regulatory hurdle.
2. Dealing with internal teams who consistently underestimate the complexity or timeline required for regulatory activities.
3. Navigating ambiguous or conflicting guidance from different global health authorities, forcing you to make high-stakes judgment calls.
4. Managing a major regulatory crisis (e.g., a product recall, a critical inspection finding) that consumes all your time and energy for weeks.
5. The constant pressure to balance speed-to-market with absolute compliance, knowing the consequences of getting it wrong are severe.

What Role Doesn't Offer

1. A quiet, predictable work environment with minimal external pressure.
2. The ability to always be the 'yes' person, especially to commercial or R&D requests.
3. A role where you're primarily hands-on with individual submissions or technical writing.
4. An environment without significant political or strategic negotiations at the highest levels of the company.

ADHD Positives

1. The fast-paced, high-stakes nature of executive decision-making can be highly engaging and stimulating, tapping into hyperfocus for critical issues.
2. The need for rapid strategic shifts and quick problem-solving in regulatory crises can align well with a dynamic, adaptable thinking style.
3. The broad scope, covering multiple products, regions, and strategic initiatives, offers constant novelty and variety, preventing boredom.

ADHD Challenges and Accommodations

1. Managing an extremely large volume of information, often with long-term implications, can be challenging. We'd support robust executive assistant support and AI tools for information synthesis.
2. The need for meticulous, long-term strategic planning and follow-through across many concurrent initiatives requires strong organisational systems. We'd encourage the use of advanced project management tools and dedicated support staff.
3. Maintaining focus during lengthy, high-level board meetings or complex policy discussions might be difficult. We'd ensure meeting agendas are clear, breaks are scheduled, and key takeaways are documented.

Dyslexia Positives

1. The strong emphasis on strategic thinking, pattern recognition in global regulatory trends, and high-level problem-solving aligns well with dyslexic strengths.
2. Excellent verbal communication and negotiation skills, critical for influencing stakeholders and health authorities, are often a strength.
3. The ability to see the 'big picture' and simplify complex regulatory landscapes into actionable strategies is highly valued.

Dyslexia Challenges and Accommodations

1. Reviewing vast, highly detailed regulatory documents (e.g., thousands of pages of guidance, submission responses) can be demanding. We'd provide access to advanced text-to-speech software, AI-powered summarisation tools, and dedicated support for detailed document review.
2. Preparing precise, error-free board-level presentations and external communications is critical. We'd ensure you have access to excellent proofreading support, grammar checkers, and tools that convert complex data into visual formats.
3. Managing highly structured data in RIM systems or GRC platforms might be challenging. We'd ensure training is visually oriented and support staff are available for data entry and verification.

Autism Positives

1. A deep commitment to logical, rule-based systems and regulatory compliance is a significant asset in this role, ensuring consistency and integrity.
2. The ability to focus intensely on complex regulatory details and identify inconsistencies or risks that others might miss is highly valued.
3. A direct, honest communication style, when appropriately adapted, can foster trust and clarity in high-stakes negotiations with health authorities and internal teams.

Autism Challenges and Accommodations

1. Navigating complex, often ambiguous social dynamics and unspoken political nuances within executive leadership and external negotiations can be difficult. We'd provide coaching on executive communication, stakeholder mapping, and offer pre-briefs for critical meetings.
2. The role involves constant, often unpredictable, shifts in global regulatory policy and urgent crises. We'd ensure clear communication of priorities, structured decision-making processes, and support for adapting to rapid changes.
3. Extensive travel and networking at industry events might be overwhelming. We'd work to optimise travel schedules, provide quiet spaces, and support you in building relationships in a way that feels comfortable and effective.

Key Responsibilities

Experience Levels Responsibilities

1. Level: C-Suite (20+ years)
2. Responsibilities: Define and articulate the enterprise-wide global regulatory strategy, ensuring it aligns with our overall business objectives and long-term vision. This means setting the direction for all regulatory activities, from early development through to post-market surveillance, across all therapeutic areas and geographies.
3. Serve as the primary interface with major global health authorities (e.g., FDA, EMA, MHRA, PMDA) at the highest levels, building and maintaining relationships that foster trust and collaboration. You'll lead critical negotiations and represent the company's position on key policy matters.
4. Establish and maintain a robust global regulatory intelligence and horizon scanning programme. You'll be the one to anticipate major shifts in the regulatory landscape, assess their enterprise-level impact, and guide the executive team on proactive mitigation strategies.
5. Lead, mentor, and develop a high-performing global regulatory affairs organisation, including multiple Director-level direct reports and their teams. This involves setting organisational structure, defining talent strategy, and fostering a culture of excellence, compliance, and strategic partnership.
6. Provide expert regulatory counsel to the CEO, Board of Directors, and other executive leaders on all critical business decisions, including M&A due diligence, portfolio prioritisation, and major R&D investments. Your input here is non-negotiable and shapes our strategic direction.
7. Oversee the management of enterprise-level regulatory risks, ensuring that robust systems are in place to identify, assess, and mitigate potential compliance failures or product safety issues. You're ultimately accountable for our regulatory posture and reputation.
8. Represent the company externally as a thought leader in global regulatory affairs, participating in key industry forums, policy discussions, and standard-setting bodies. This means shaping the future of regulation, not just reacting to it.
9. Supervision: You'll operate with full strategic autonomy, reporting directly to the CEO. Your work will be guided by the company's overall strategic objectives and board governance, with monthly or quarterly strategic alignment discussions with the CEO and Board. You're expected to be self-directed and proactive, setting your own agenda to achieve enterprise goals.
10. Decision: You'll have full strategic authority for global regulatory affairs, including setting the function's budget (typically £10M+), organisational design, and talent acquisition. You'll make final decisions on major regulatory submissions, health authority interactions, and enterprise-level compliance policies. Board-level decisions (e.g., major M&A regulatory risk acceptance, significant policy changes) require CEO and Board alignment.
11. Success: Success at this level means our company consistently achieves timely regulatory approvals for our priority products globally, maintains an impeccable compliance record with zero critical findings, and is recognised as a leader in ethical and effective regulatory affairs. It means your strategic foresight has prevented major crises and enabled significant commercial opportunities. Ultimately, it means the CEO and Board view you as an indispensable strategic partner who safeguards our future.

Decision-Making Authority

• Type: Global Regulatory Strategy Definition
• Entry: N/A
• Mid: N/A
• Senior: N/A
• Type: Major Health Authority Interaction Strategy
• Entry: N/A
• Mid: N/A
• Senior: N/A
• Type: Enterprise Regulatory Risk Acceptance
• Entry: N/A
• Mid: N/A
• Senior: N/A
• Type: Regulatory Affairs Organisational Structure & Budget
• Entry: N/A
• Mid: N/A
• Senior: N/A

Competency Requirements

Foundation Skills (Transferable)

At this executive level, your foundation skills aren't just about personal effectiveness; they're about leading an entire function, influencing the C-suite, and shaping the company's direction. We expect mastery in these areas, not just competence.

• Category: Strategic Leadership & Vision
• Skills: Ability to define and articulate a compelling, multi-year global regulatory strategy that directly supports the company's overall business objectives.
• Proven track record of building and developing high-performing, geographically dispersed regulatory teams, fostering a culture of excellence and compliance.
• Exceptional capability to identify and cultivate future regulatory leaders, ensuring robust succession planning for critical roles.
• Demonstrated ability to inspire and motivate a large organisation through periods of significant change, regulatory uncertainty, or crisis.
• Category: Executive Communication & Influence
• Skills: Mastery of executive-level communication, capable of distilling complex regulatory science and policy into clear, concise, and actionable insights for the CEO, Board, and other non-regulatory executives.
• Highly developed negotiation and diplomatic skills, essential for leading high-stakes discussions with global health authorities, industry bodies, and internal stakeholders.
• Ability to build and maintain strong, credible relationships with key external stakeholders, including regulators, government officials, and industry leaders.
• Expertise in managing media relations and public perception during regulatory crises or significant announcements.
• Category: Enterprise Risk Management & Governance
• Skills: Deep understanding and practical application of enterprise risk management principles, specifically as they apply to regulatory compliance and product safety.
• Proven ability to establish and oversee robust governance frameworks for regulatory decision-making, ensuring accountability and transparency.
• Experience in managing regulatory aspects of M&A activities, including due diligence, integration, and risk assessment.
• Expertise in navigating complex legal and ethical considerations related to global regulatory affairs.
• Category: Business Acumen & Commercial Insight
• Skills: Profound understanding of the pharmaceutical/medical device industry's commercial drivers, market dynamics, and competitive landscape.
• Ability to translate regulatory strategy into tangible business value, demonstrating how compliance and smart regulatory pathways contribute to revenue and market share.
• Strong financial literacy, including P&L management, budget allocation for a large function, and understanding of investment returns related to regulatory activities.
• Capacity to balance regulatory imperatives with commercial objectives, finding compliant solutions that enable business growth.

Functional Skills (Role-Specific Technical)

You're not just a regulatory expert; you're a global authority. These are the deep domain skills that allow you to lead, strategise, and influence at the highest levels, ensuring our products navigate the world's most complex regulatory environments.

Technical Competencies

• Skill: Global Regulatory Strategy Definition & Execution
• Desc: The ability to architect and implement comprehensive, integrated regulatory strategies for entire product portfolios or therapeutic areas across all major global markets (e.g., US, EU, JP, China, LATAM). This includes defining submission sequencing, identifying reliance pathways, and adapting strategies to geopolitical shifts. You're not just following a strategy; you're creating it.
• Level: Expert
• Skill: Health Authority Engagement & Negotiation (Executive Level)
• Desc: Mastery of managing high-stakes interactions with global health authority leadership. This involves leading scientific advice meetings, negotiating complex labelling content, responding to critical inspection findings, and influencing policy development. You're our chief diplomat with the regulators.
• Level: Expert
• Skill: Regulatory Intelligence & Horizon Scanning (Strategic)
• Desc: The capability to establish and oversee a world-class regulatory intelligence function. This means not just collecting data, but proactively predicting future regulatory changes, assessing their enterprise-wide impact, and developing proactive mitigation or opportunity capture strategies. You're looking years ahead.
• Level: Expert
• Skill: CMC Regulatory Affairs (Strategic Oversight)
• Desc: While not hands-on, you'll have a profound strategic understanding of Chemistry, Manufacturing, and Controls (CMC) regulatory requirements globally. You'll guide decisions on manufacturing site changes, process validations, and supply chain resilience from a regulatory perspective, understanding the impact on product availability and compliance.
• Level: Advanced
• Skill: Advertising & Promotion Compliance (Global Policy)
• Desc: Expertise in setting global policies and governance for advertising and promotion, ensuring all commercial communications adhere to local and international regulations. You'll balance commercial ambition with regulatory risk, protecting the company's reputation and avoiding enforcement actions.
• Level: Expert
• Skill: M&A Regulatory Due Diligence & Integration
• Desc: The ability to lead and conduct thorough regulatory due diligence for potential mergers and acquisitions, identifying critical risks and opportunities. You'll then oversee the regulatory integration of acquired assets, ensuring seamless compliance and portfolio alignment.
• Level: Advanced

Digital Tools

• Tool: Veeva Vault RIM Suite
• Level: Strategic
• Usage: Overseeing platform governance, making strategic decisions on new module implementations (e.g., Submissions, Registrations), and using RIM data for strategic portfolio planning and executive reporting. You'll ensure the system supports our global regulatory objectives.
• Tool: Lorenz docuBridge / EXTEDO eCTDmanager
• Level: Architect
• Usage: Not a hands-on user, but you'll understand publishing timelines and resource needs to inform strategic planning and budget allocation. You'll be involved in vendor selection and validation strategy for these critical submission tools.
• Tool: Cortellis / Tarius (Regulatory Intelligence)
• Level: Strategic
• Usage: Using intelligence data to shape global regulatory strategy, identify opportunities for expedited pathways, and brief executive leadership on geopolitical or regulatory risks. You'll direct your team on how to best use these tools for horizon scanning.
• Tool: MasterControl / TrackWise Digital (QMS)
• Level: Strategic
• Usage: Ensuring alignment between our Quality Management System and global regulatory requirements. You'll use QMS metrics for management reviews and to report on our quality posture to health authorities during inspections, ensuring enterprise-wide compliance.
• Tool: ServiceNow GRC / Archer GRC Suite
• Level: Advanced
• Usage: Owning the regulatory risk register within the GRC platform, defining key risk indicators (KRIs), and using the system to report on our overall compliance posture to the board and risk committee. You're the ultimate owner of regulatory risk visibility.
• Tool: Power BI / Tableau
• Level: Expert
• Usage: Designing and building executive-level dashboards that integrate data from RIM, QMS, and finance systems to provide a holistic, real-time view of the regulatory function's business impact, performance, and risk profile. You'll use these for board presentations.
• Tool: Diligent / BoardVantage (Board Reporting)
• Level: Advanced
• Usage: Preparing and uploading board materials related to significant regulatory approvals, critical compliance risks, or upcoming health authority interactions. You'll ensure all board communications are precise, impactful, and compliant.

Industry Knowledge

• Area: Global Pharmaceutical/Medical Device Regulatory Landscape
• Desc: Deep, nuanced understanding of the regulatory frameworks, agencies, and political dynamics in all major global markets, including emerging markets. This isn't just about knowing the rules; it's about understanding the unwritten norms, the key players, and how to operate effectively within diverse systems.
• Area: Drug/Device Development Lifecycle
• Desc: Comprehensive knowledge of the entire drug or device development process, from discovery and preclinical research through clinical trials, manufacturing, and post-market surveillance. You'll understand how regulatory strategy integrates at every stage to optimise development pathways.
• Area: Pharmacovigilance & Post-Market Safety
• Desc: Strategic oversight of pharmacovigilance and post-market safety reporting requirements globally. You'll understand the regulatory implications of safety signals and how to manage communications with health authorities during critical safety events.
• Area: Biologics/Advanced Therapies Regulatory Science
• Desc: Expertise in the unique regulatory challenges and pathways for biologics, gene therapies, cell therapies, or other advanced therapeutic modalities, if relevant to our pipeline. This requires a deep understanding of cutting-edge science and its regulatory interpretation.

Regulatory Compliance Regulations

• Reg: ICH Guidelines (e.g., E6, Q10, M4)
• Usage: Setting enterprise-wide standards for clinical trial conduct, quality systems, and dossier structure, ensuring global harmonisation where possible and influencing future guideline development.
• Reg: FDA Regulations (e.g., 21 CFR Parts 312, 314, 801, 807, 820)
• Usage: Defining our US regulatory strategy, leading interactions with FDA leadership, and ensuring full compliance with US drug and device regulations across all aspects of our business.
• Reg: EU Directives & Regulations (e.g., EMA Procedures, MDR/IVDR, GMP, GCP)
• Usage: Shaping our EU regulatory strategy, overseeing interactions with the EMA and national competent authorities, and ensuring our products comply with the complex European regulatory framework.
• Reg: Global Health Authority Requirements (e.g., PMDA, NMPA, Health Canada, TGA)
• Usage: Establishing and overseeing regulatory strategies for market access and lifecycle management in all other key global markets, adapting to local nuances and influencing regional policy.
• Reg: Anti-Bribery & Corruption (e.g., UK Bribery Act, FCPA)
• Usage: Ensuring regulatory interactions and external engagements (e.g., with government officials, consultants) are conducted with the highest ethical standards and in full compliance with anti-bribery laws globally.

Essential Prerequisites

• A minimum of 20 years of progressive experience in global regulatory affairs within the pharmaceutical, biotechnology, or medical device industry, with at least 10 years in a senior leadership role (e.g., Director or above) overseeing multi-regional teams.
• Demonstrated success in leading multiple major product approvals (e.g., MAA, NDA, BLA) in at least two major global markets (e.g., US and EU) from early development through to launch.
• Extensive experience in managing and influencing relationships with senior health authority officials and participating in industry policy-setting bodies.
• A proven track record of building, mentoring, and retaining high-performing global regulatory teams.
• Deep strategic understanding of regulatory intelligence, risk management, and compliance frameworks at an enterprise level.
• Significant experience in providing executive-level counsel to CEOs, Boards, and other C-suite leaders on regulatory strategy and risk.

Career Pathway Context

Frankly, you've likely spent years, if not decades, honing your craft through roles like Regulatory Affairs Manager, Associate Director, and Director. You've seen it all, from early-stage development to post-market challenges, and you've led teams through complex global submissions. This isn't a role you 'fall into'; it's the culmination of a distinguished career in regulatory affairs, where you've consistently demonstrated strategic foresight, leadership, and an unwavering commitment to compliance.

Qualifications & Credentials

Emerging Foundation Skills

• Skill: AI-Powered Regulatory Foresight & Policy Influence
• Why: AI is rapidly transforming how regulatory intelligence is gathered, analysed, and how policy impacts are modelled. Regulators themselves are starting to use AI, and companies that don't use it to predict and influence future policy will be left behind. This isn't just about efficiency; it's about strategic advantage and proactive risk mitigation.
• Concepts: [{'concept_name': 'Predictive Analytics for Regulatory Trends', 'description': 'Using machine learning to identify patterns in global health authority communications, legislative changes, and public health data to forecast future regulatory priorities and shifts.'}, {'concept_name': 'AI-Assisted Policy Drafting & Advocacy', 'description': 'Employing LLMs to draft initial policy positions, white papers, or responses to public consultations, allowing your team to focus on strategic nuance and advocacy.'}, {'concept_name': 'Simulation of Regulatory Impact', 'description': 'Using AI to model the potential commercial and operational impact of proposed regulations across different markets and product lines, informing our lobbying efforts.'}, {'concept_name': 'Ethical AI in Regulatory Decision-Making', 'description': 'Understanding the ethical implications of using AI in regulatory submissions and compliance, ensuring transparency, fairness, and avoiding bias.'}]
• Prepare: This quarter: Engage with leading AI regulatory intelligence vendors to understand their capabilities and limitations. Identify a pilot project.
• Next 6 months: Lead a cross-functional working group to define our company's strategy for AI in regulatory affairs, including governance and ethical guidelines.
• Next 12 months: Implement an enterprise-grade AI regulatory foresight platform and integrate its insights into executive strategic planning.
• Ongoing: Actively participate in industry forums discussing AI's role in regulation, shaping best practices and influencing future policy.
• QuickWin: Start using advanced AI summarisation tools (e.g., Claude, ChatGPT Enterprise) for all complex regulatory documents and policy updates today. It'll save you hours and give you a head start.

Advancing Technical Skills

• Skill: Advanced Digital Regulatory Information Management (RIM) Strategy
• Why: Regulatory Information Management (RIM) systems are becoming more sophisticated, integrating with other enterprise systems (QMS, ERP, Clinical). Your role is to ensure our RIM strategy supports global harmonisation, data integrity, and provides actionable insights for executive decision-making, moving beyond just document management.
• Concepts: [{'concept_name': 'RIM-QMS-ERP Integration', 'description': 'Understanding how regulatory data flows across core enterprise systems to ensure consistency, reduce manual effort, and enhance data integrity for compliance.'}, {'concept_name': 'Data Governance for Regulatory Submissions', 'description': 'Establishing policies and processes to ensure the quality, consistency, and traceability of all data used in regulatory submissions and compliance reporting.'}, {'concept_name': 'Predictive Analytics from RIM Data', 'description': 'Using historical RIM data (e.g., submission timelines, agency query types) to predict future challenges and optimise regulatory processes.'}, {'concept_name': 'Blockchain for Supply Chain Traceability & Compliance', 'description': 'Exploring the potential of blockchain technology to enhance the traceability of product components and ensure compliance throughout the global supply chain.'}]
• Prepare: This quarter: Review our current RIM system's capabilities and limitations with your team. Identify key areas for strategic enhancement.
• Next 6 months: Develop a multi-year roadmap for our global RIM strategy, focusing on integration, data governance, and advanced analytics capabilities.
• Next 12 months: Lead the evaluation and selection of next-generation RIM technologies or significant upgrades, ensuring they align with our long-term regulatory vision.
• Ongoing: Champion a data-driven culture within Regulatory Affairs, using RIM data to inform strategic decisions and demonstrate functional value.
• QuickWin: Work with your IT and Data teams to ensure our existing RIM system is fully integrated with our executive dashboards (Power BI/Tableau) to provide real-time strategic insights.

Education Requirements

• Level: Minimum
• Req: A Bachelor's degree in a scientific discipline (e.g., Pharmacy, Chemistry, Biology, Medicine) or a related field.
• Alts: Extensive, demonstrable experience (25+ years) in global regulatory affairs with a proven track record of executive leadership and major product approvals could be considered in lieu of a Bachelor's degree, though this is rare at this level. A Master's degree or PhD is usually expected.
• Level: Preferred
• Req: A Master's degree (MSc) or PhD in a scientific or regulatory affairs discipline, or an MBA with a focus on healthcare or life sciences.
• Alts: N/A

Experience Requirements

You'll need at least 20 years of progressively responsible experience in global regulatory affairs within the pharmaceutical, biotechnology, or medical device industry. This must include a minimum of 10 years in senior leadership roles (Director or VP level) where you've been accountable for setting and executing multi-regional regulatory strategies and managing large, diverse teams. We're looking for someone who has successfully led multiple major product approvals (e.g., MAA, NDA, BLA) in at least two major global markets (like the US and EU) from early development right through to post-market. Experience managing regulatory aspects of M&A or significant portfolio divestitures is also highly valued. Frankly, you've seen it all, and you've led through it.

Preferred Certifications

• Cert: Regulatory Affairs Certification (RAC) Global
• Prod: RAPS (Regulatory Affairs Professionals Society)
• Usage: Demonstrates a comprehensive understanding of global regulatory requirements and best practices, reinforcing your professional credibility in the field.
• Cert: Certified Compliance & Ethics Professional (CCEP)
• Prod: SCCE (Society of Corporate Compliance and Ethics)
• Usage: Highlights your expertise in broader compliance frameworks and ethical leadership, which is critical for managing enterprise-level regulatory risk and governance.

Recommended Activities

• Active participation and leadership roles in key industry trade associations (e.g., EFPIA, PhRMA, RAPS, BIO), influencing policy and best practices.
• Regular engagement with global health authority leadership through formal meetings, workshops, and advisory committees.
• Attending and speaking at major international regulatory conferences and scientific symposia.
• Continuous learning in emerging regulatory science (e.g., AI in drug development, advanced therapies, digital health regulations) and executive leadership development programmes.
• Mentoring rising talent within the regulatory affairs profession, both internally and externally.

Career Progression Pathways

Entry Paths to This Role

• Path: From Director, International Regulatory Affairs (L6)
• Time: 3-5 years at Director level
• Path: From a Head of Regulatory Affairs in a smaller/mid-sized company
• Time: 5-7 years as Head of Regulatory Affairs
• Path: From a Senior Role at a Global Health Authority (e.g., FDA, EMA)
• Time: 5-10 years in a senior leadership role at a major health authority

Career Progression From This Role

• Pathway: Chief Compliance Officer (CCO)
• Time: 3-5 years
• Pathway: Chief Executive Officer (CEO) of a smaller/mid-sized life sciences company
• Time: 5-10 years

Long Term Vision Potential Roles

• Title: Chief Compliance Officer (CCO)
• Time: 3-5 years post-VP
• Title: Chief Executive Officer (CEO) of a smaller life sciences company
• Time: 5-10 years post-VP
• Title: Board Member / Non-Executive Director (NED)
• Time: 5-10 years post-VP (often concurrently with other roles)
• Title: Global Regulatory Policy Leader (e.g., at a major industry association or WHO)
• Time: 5-10 years post-VP

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.