UK

United Kingdom · Compliance, quality and safety · Director/VP (16-20 years)

Director, International Regulatory Strategy

Here is the whole job, in plain words. What it is, what you decide, how you're judged, how people get here and where they go next. Then the part no course gives you: twelve AI tutors who learn your work.

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  • Experience bandDirector/VP (16-20 years)
  • Direct reports25-100+ reports
  • Reports toVP / Chief Regulatory & Compliance Officer
  • UK framework levelUsually a director, accountable for a division and its numbers

Also advertised as Head of Global Regulatory Affairs · VP Regulatory Compliance (Strategy) · Senior Director, Regulatory Affairs & Policy

Built on 43,079 real UK job descriptions we analysed · grounded in what real qualifications cover

Two short quizzes about you

1From this job to a course

The qualifications matched to this job

GQA Level 5 Diploma in the Practice of Process Safety Management GQA Qualifications Limited · Level 5 · covers 4 of 9 standards
GQA PAA\VQ-SET Level 3 Diploma for a Bulk Storage Operator (Technician) GQA Qualifications Limited · Level 3 · covers 1 of 9 standards
GQA PAA\VQ-SET Level 3 Certificate in Laboratory Technical Skills GQA Qualifications Limited · Level 3 · covers 1 of 9 standards
CICM Level 5 Diploma in Credit and Collections Management Chartered Institute of Credit Management · Level 5 · covers 1 of 9 standards

Matched from the standards this job is measured against: a suggestion, not an official ruling.

The units you would start with

Understand how to comply with the relevant Regulations, Industry Standards and Management Requirements for Process Safety GQA Level 5 Diploma in the Practice of Process Safety Management
Principles of Safe Manufacture of Quality Medicines in the Pharmaceutical Environment Open Awards Level 3 Technical Occupational Entry in the Principles and Practice for Pharmacy Technicians (Diploma)
Comply with External and Internal Obligations within a Bulk Storage Operations Environment GQA PAA\VQ-SET Level 3 Diploma for a Bulk Storage Operator (Technician)
Good Manufacturing Practice GQA PAA\VQ-SET Level 3 Certificate in Laboratory Technical Skills
Compliance with legal, regulatory, ethical and social requirements CICM Level 5 Diploma in Credit and Collections Management

The future skills this job leans on

AI Fluency working with AI as a thinking partner
AI Governance Fluency using AI responsibly
Automation Fluency building AI into how work runs
Your Plan Illustration

Built for Director, International Regulatory Strategy

5 units that map to this job, from the qualifications that cover it.

  1. Understand how to comply with the relevant Regulations, Industry Standards and Management Requirements for Process Safety GQA Qualifications Limited · covers 4 of 9 standards Level 5
  2. Principles of Safe Manufacture of Quality Medicines in the Pharmaceutical Environment Open Awards · covers 4 of 9 standards Level 3
  3. Comply with External and Internal Obligations within a Bulk Storage Operations Environment GQA Qualifications Limited · covers 1 of 9 standards Level 3
  4. Good Manufacturing Practice GQA Qualifications Limited · covers 1 of 9 standards Level 3
  5. Compliance with legal, regulatory, ethical and social requirements Chartered Institute of Credit Management · covers 1 of 9 standards Level 5
These are the real units behind this job, in the order they rank for it. Nothing here is marked done, because this plan has not been started by anyone yet. Yours would fill in as you go.

2AI and this work

Will AI change your work as a Director, International Regulatory Strategy?

Nobody can say exactly how. Here is what this job is being asked for next, and where to start.

The new skills this role is being asked for

  • AI & Automation Strategy for Compliance
  • Global Regulatory Harmonisation & Divergence Management
Why each one is rising

The future skills this job leans on

We'll only ever tell you what we can actually back up. No hype, no scare tactics.

What happens when you start

Next, a free account. We build your Director, International Regulatory Strategy plan as you set up, starting with the free Automation Fluency module. No card.

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Keep this read. One email with what AI is changing in this job, the new skills it asks for and where to start free. Nothing else follows unless you confirm your address.

3What this role really is

This role sets the multi-year regulatory strategy for a business unit across international markets, deciding how products can be sold without legal risk.

4What you'd actually use

The tools this job runs on, and how well you'd need to know each one.

ServiceNow GRC / Veeva Vault (QualityDocs/Submissions) Strategic

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.

Enhesa / RegScan / Thomson Reuters Regulatory Intelligence Strategic

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.

Lorenz docuBridge / eCTD Express Architect

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).

MS Teams (with SharePoint integration) / Jira / Confluence Strategic

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.

Power BI / Tableau Server / Diligent Boards Strategic

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.

5What you get to decide, and how that grows

Power in a job isn't your title. It's what you're allowed to decide. Here's how it grows as you move up.

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

6How you'll be judged

The scoreboard, and what is not on it. The hard targets, how often each is actually looked at, and the quiet signals that never reach a dashboard.

New Market Entry Success Rate
The percentage of targeted new international markets where we successfully gain regulatory approval and launch products within the planned timeframe.
Target · Achieve >80% success rate for strategic market entries.

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.

Time-to-Market Reduction (Regulatory Phase)
The average reduction in the regulatory approval phase for new product launches across key international markets, compared to historical averages or industry benchmarks.
Target · Reduce average regulatory time-to-market by 15-20% year-on-year.

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.

Regulatory Audit & Inspection Outcome
The number and severity of findings from major health authority inspections (e.g., FDA 483s, EMA inspections, Notified Body audits) for your business unit.
Target · Zero 'Official Action Indicated' (OAI) or 'Major Critical' findings; aim for 'No Action Indicated' (NAI) or 'Minor Observations' in >95% of audits.

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.

Cost of Non-Compliance & Regulatory Fines
The total financial impact of regulatory penalties, fines, product recalls, or market withdrawals directly attributable to a failure in regulatory strategy or oversight.
Target · Zero significant regulatory fines or product recalls due to strategic compliance failures for your business unit.

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.

Strategic Influence & Counsel
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.
  • 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'.
Team Leadership & Capability Building
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.
  • 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.
External Reputation & Agency Relationships
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.
  • 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.
Proactive Risk Anticipation
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.
  • 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.

7Would you like it

Both sides. What people enjoy, and what grinds them down.

What people enjoy
Strategic Impact & Business Protection

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.

Successfully navigating a complex new regulation in a major market, allowing a £50M product launch to proceed on schedule, avoiding potential delays or penalties.

Solving Complex, Ambiguous Problems

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.

Developing a novel regulatory pathway for a truly innovative product where no clear precedent exists, requiring deep analysis and proactive agency engagement.

Building & Leading High-Performing Teams

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.

Seeing a manager you've coached successfully lead a critical agency negotiation, or watching a specialist you've mentored take on a more senior, strategic role.

What frustrates people
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 this role does not give you
  • Predictable, routine tasks: Every day brings new regulatory challenges and ambiguities.
  • Instant gratification: Regulatory approvals can take years, and strategic impact unfolds over multi-year horizons.
  • Complete control: You'll be influencing, not dictating, across many functions and external bodies.

8Who you work with

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.

Inside the business
  • 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)
Outside the business
  • 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)

9What you need before you start

Not a wish list. The things you would be expected to already have.

  • 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.

10What to practise next

Where the job is going, and what to do about it starting this week.

Advanced GRC/QMS System Architecture

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.

Enterprise System Integration · Data Governance for Compliance · Cloud-Native Compliance Solutions

  • 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.

Quick win: 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.

11Staying current once you are in

What people here do to keep up
  • 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.

12The rising capability

The rising capability

Zavmo analysis

What's rising in its place

This is where the work is heading, and the higher pay with it. Get fluent here and the shift stops being a threat and starts being your edge.

AI & Automation Strategy for Compliance

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.

  • Regulatory AI Governance
  • Process Re-engineering with AI
  • Vendor Selection & Integration
  • Predictive Compliance Modelling

Global Regulatory Harmonisation & Divergence Management

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.

  • Harmonisation Initiatives
  • Divergence Impact Assessment
  • Modular Submission Strategies
  • Regulatory Agility Models

13What you’ll use

What you’ll use

Skills this role draws on

Technical

  • Regulatory Pathway Assessment (Strategic)
  • Horizon Scanning & Impact Analysis (Enterprise-wide)
  • Gap Analysis & Remediation Planning (Strategic Oversight)
  • Regulatory Agency Engagement (Executive Level)
  • Change Control Governance (Global Framework)
  • Post-Market Surveillance (PMS) & Vigilance Reporting (Strategic Oversight)

14The pathway

The pathway

How you actually get there, here

How you become one varies far more by country than what one does. This is the UK route. Most people take one of these ways in; the right one depends on where you're starting from.

  1. 1

    From Senior Manager, International Regulatory Strategy (L5)

    3-5 years at L5

    Skills to master

    • At L5, you'd have already managed a team and developed global strategies for a business unit. To step up to Director, you need to demonstrate consistent success in driving strategic outcomes, building organisational capability, and owning significant P&L impact. You'll also need to prove your ability to influence at the C-suite level and manage cross-functional leaders.

    You're ready to move on when

    • Successfully led 2-3 major market entry programmes (e.g., EU MDR, US PMA) from strategy to approval.
    • Developed and implemented a new global regulatory process that significantly improved efficiency or compliance.
    • Consistently received strong feedback on your ability to mentor and develop managers within your team.
    • Demonstrated clear strategic thinking in ambiguous situations, making decisive calls that protected the business.
  2. 2

    From Head of Regulatory Affairs (Mid-Sized Company)

    4-6 years in a similar leadership role

    Skills to master

    • If you're coming from a smaller company, you'll likely have broader experience across all regulatory functions. Here, you'll need to demonstrate your ability to scale those skills to a larger, more complex, and geographically diverse organisation. This means proving you can manage larger teams, navigate more intricate internal politics, and operate with a higher degree of strategic foresight.

    You're ready to move on when

    • Successfully built and scaled a regulatory function in a growing company.
    • Managed significant interactions with major health authorities, leading to successful product approvals.
    • Developed and implemented a robust QMS that passed external audits with minimal findings.
    • Proven ability to attract, retain, and develop high-calibre regulatory talent.

15Where this role leads

The long view: This work can lead to a Chief Regulatory and Compliance Officer role, a VP of Global Market Access and Regulatory Affairs role, or a Distinguished Regulatory Strategist position.

The ten Future Fluencies

Zavmo analysis

The credential is what you can do today. These are what keep you valuable.

A qualification proves you can do the job as it's defined today. These ten are what decide whether you're still the obvious person for it in five years. They're the capabilities employers are now writing into senior roles faster than people are learning them. Zavmo weaves them through whatever you study, so you come out with both: the credential and the fluency.

The highlighted ones are the Fluencies your role leans on hardest, from how Director, International Regulatory Strategy is actually changing.

Where it leads

Roles this leads to

The record names a next step, but the catalogue has no page for it yet:

  • VP / Chief Regulatory & Compliance Officer (L7)

How you would learn this

One to one, on the work you already do

A tutor sets the task against your own job and marks the reasoning, at your pace. There is no cohort to fall behind.

A lesson from Understand how to comply with the relevant Regulations, Industry Standards and Management Requirements for Process Safety, worked against Director, International Regulatory Strategy.

Understand how to comply with the relevant Regulations, Industry Standards and Management Requirements for Process Safety Level 5

Applied to your work in Director, International Regulatory Strategy

The objective of this unit is to provide learners with a comprehensive understanding of the regulations, industry standards, and management requirements for process safety. Learners will understand the role of the Process Safety Leadership Group, relevant frameworks, legal duties, and the role of the Competent Authority.

How the thinking builds
  1. 1 Remember
  2. 2 Understand
  3. 3 Apply
  4. 4 Analyse
  5. 5 Evaluate
  6. 6 Create
An illustration of a Zavmo lesson, built from this role’s own route. The unit, its objective and every criterion above are the awarding body’s own words, not an example.

It is £70 a month, billed monthly. Your free first module is Future Fluency, and you can cancel any time.

See Your Progress Grow Illustration
Director, International Regulatory Strategy
  • Regulatory Pathway Assessment (Strategic)
  • Horizon Scanning & Impact Analysis (Enterprise-wide)
  • Gap Analysis & Remediation Planning (Strategic Oversight)
  • Regulatory Agency Engagement (Executive Level)
  • Change Control Governance (Global Framework)
  • Post-Market Surveillance (PMS) & Vigilance Reporting (Strategic Oversight)
This is your Mind Palace on learn.zavmo.ai. Every skill above comes from this role's own record, not an example borrowed from another job. A node lights up when you evidence it, and what you build stays yours between jobs. That is the part a course cannot do.

16The detail, folded away

Everything else the record holds

The career branches in full, how AI is already showing up in the day-to-day, and the questions people ask about this job. Here when you want them, out of the way while you decide.

Where it leads next, rung by rung

Where it leads

The career path, and where it branches

Director, International Regulatory Strategy is a start, not a ceiling. Each step below asks for new skills and hands back more autonomy.

  1. VP / Chief Regulatory & Compliance Officer (L7)

    3-5 years as Director

    This is the ultimate step up, moving from shaping business unit strategy to driving enterprise-wide compliance and influencing industry standards. You'll be accountable for the entire company's regulatory risk profile.

    • Enterprise Risk Management (ERM) Integrating regulatory risk into the broader ERM framework, providing a holistic view of corporate risk.
    • M&A Strategy & Integration (Executive Level) Leading the regulatory aspects of major M&A deals, from strategic assessment to post-acquisition integration across the entire enterprise.
    • Crisis Management (Regulatory) Leading the company's response to major regulatory crises, product recalls, or public scrutiny.
    • Digital Transformation Leadership Championing the digital transformation of the entire compliance function, leveraging advanced analytics and AI across all departments.
Working with AI on the job

Working with AI

Where AI is starting to help

Let's be real, the regulatory landscape is only getting more complex, and the sheer volume of information can be overwhelming. This isn't about replacing your expertise; it's about giving you superpowers. Imagine having an AI assistant that handles the grunt work, leaving you free to focus on the high-value strategic thinking that only you can do.

For a Director of International Regulatory Strategy, AI isn't just a buzzword; it's a critical tool for maintaining a competitive edge and managing risk. We're talking about automating the mundane, accelerating insights, and even predicting future challenges. Our AI Productivity Hub is packed with tools specifically designed to make your life easier and your strategies sharper.

Automated Dossier Compilation

Forget the endless copy-pasting and formatting nightmares. AI tools can scan your technical files, lab reports, and design specifications to auto-populate huge sections of standardised submission dossiers (like STED or eCTD). This ensures consistency and drastically cuts down on manual data entry, freeing up your team for more critical tasks.

Regulatory Change Radar

Stop drowning in regulatory updates. Our AI-powered horizon scanning constantly monitors global regulatory databases, news sites, and government publications. It automatically summarises changes relevant to your specific product portfolio and flags high-impact updates, giving you a massive head start on strategic planning. No more missing critical deadlines because you didn't spot a subtle rule change.

Predictive Agency Query Tool

Imagine knowing the questions before they're asked. By feeding an LLM your company's historical submissions and agency feedback, the AI can predict the top 5-10 likely questions or requests for information (RTQs) from a regulator for a new submission. This means your team can prepare responses proactively, significantly speeding up approval cycles and reducing back-and-forth.

Technical-to-Business Translator

Ever struggled to explain a complex regulatory challenge to the sales team or the CEO? This AI assistant drafts plain-language summaries of intricate regulatory issues or technical product problems. It creates clear, concise briefing notes for executive leadership or commercial teams who simply don't have your deep technical expertise, saving you hours of explanation and ensuring everyone's on the same page.

Common questions

Common questions

How do you become a Director, International Regulatory Strategy?

Common routes in include From Senior Manager, International Regulatory Strategy (3-5 years at L5) and From Head of Regulatory Affairs (Mid-Sized Company) (4-6 years in a similar leadership role). Times vary with prior experience.

Where can a Director, International Regulatory Strategy progress to?

This role can lead on to VP / Chief Regulatory & Compliance Officer (3-5 years as Director), depending on the skills you build.

What new skills matter most for a Director, International Regulatory Strategy?

Increasingly, AI & Automation Strategy for Compliance and Global Regulatory Harmonisation & Divergence Management. These are the skills our record of this role lists as growing.

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17Where to go from here

Other roles at Level 7

Same depth of qualification, different job. Useful if the work appeals but this particular role does not.

 More jobs in compliance, quality and safety

Stay in the field you know and move sideways rather than up.
If you leave this industry

Skills in handling complex international regulatory work carry across industries. They can lead to senior regulatory roles in pharmaceuticals, biotechnology or food and beverage, or to regulatory consulting work advising several clients on global compliance.

This role profile is © 2026 Growth Engineering Technologies Ltd. Built from UK occupational standards and regulated qualification data, and written for Zavmo.

You're not behind. You're right on time. The shift is only just beginning. Your role won't look the same in two years. Be the one who leads the change, not the one it happens to. Start my free Automation Fluency module What happens next: a free account, then we build your plan as you set up. No card. Build your plan, see your roadmap and meet the twelve tutors matched to you. All free. When you're ready to start learning, it's £70 a month, billed monthly. Cancel any time and billing stops.