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- Tasks: Lead global regulatory policy and intelligence, shaping strategies for R&D and commercial functions.
- Company: Join a pioneering biopharma company with a focus on innovation and compliance.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Why this job: Make a significant impact in the biopharma industry by influencing regulatory strategies.
- Qualifications: Advanced degree and 12+ years in regulatory affairs with leadership experience required.
- Other info: Collaborative environment with a strong emphasis on cross-functional teamwork.
The predicted salary is between 72000 - 108000 £ per year.
The Director/Senior Director, Global Regulatory Policy & Intelligence is a strategic leader responsible for building and executing a global regulatory policy and intelligence capability that anticipates, shapes, and translates regulatory change into actionable strategies across R&D, regulatory submissions, product lifecycle and commercial functions. This role leads two integrated areas — Regulatory Policy (advocacy, guidance response, stakeholder engagement) and Regulatory Intelligence (systematic monitoring, analysis, dissemination and forecasting) - ensuring the company is proactive, compliant, and influential in key markets. This position is hybrid onsite and remote working and will be primarily located at one of Alnylam's international hubs (Maidenhead UK, Amsterdam, Netherlands or Zug, Switzerland).
Key Responsibilities
- Strategic leadership & team management
- Build, lead and mentor the Global Regulatory Policy & Intelligence team across regions; set priorities, operating model, and KPI framework.
- Align Policy & Intelligence deliverables with corporate R&D and commercial priorities; ensure timely inputs to program teams and enterprise leadership.
- Develop or enhance capability (tools, data sources, dashboards) for efficient intelligence collection, analysis and dissemination.
- Regulatory Policy (advocacy & interpretation)
- Lead the company's global responses and positioning on major regulatory guidances, proposed legislation and standards impacting drug/devices/combination products.
- Coordinate cross-functional internal consultations and prepare formal comments and position papers for submission to regulators and for use in industry forums.
- Represent the company in external stakeholder engagements including industry associations, expert working groups and regulatory roundtables.
- Provide strategic counsel to senior leadership on policy risks and opportunities affecting development plans, labeling, advertising/commercial, and market access.
- Regulatory Intelligence (monitoring & analysis)
- Design and run a proactive regulatory intelligence program: horizon scanning, monitoring regulator outputs (FDA, EMA, PMDA, Health Canada, other agencies), national legislation, and relevant standards/best practices.
- Translate raw intelligence into concise, prioritized briefings, impact assessments, and decision support for product teams and functions (Clinical, PV, CMC, Quality, Commercial, Legal).
- Maintain and continuously improve a regulatory intelligence repository and alerts system; evaluate vendors and data sources as needed.
- Cross-functional integration & advisory
- Serve on cross-functional development program teams (as policy/intelligence subject matter leader) to advise on regulatory strategy and to de-risk development and lifecycle decisions.
- Develop training and communications (newsletters, workshops, playbooks) to raise regulatory policy awareness across the company.
- Partner with Government Affairs, Legal, Medical Affairs, Market Access, CMC and Commercial to ensure consistent external messaging and alignment of advocacy activities.
- Governance, metrics & quality
- Establish KPIs (e.g., time-to-impact assessment, number of policy submissions, quality of intelligence products, stakeholder satisfaction) and report outcomes to leadership.
- Ensure high standards of scientific and regulatory rigor in position papers and intelligence outputs; manage confidentiality and information governance.
Qualifications
- Advanced degree (PharmD, PhD, MD, or MSc) or JD with substantial regulatory/scientific exposure preferred.
- 12+ years' experience in regulatory affairs, policy, public affairs or regulatory intelligence in the biopharma industry, including 8+ years in a leadership role.
- Demonstrated experience developing regulatory policy positions and submitting comments to regulators, and experience running regulatory intelligence programs.
- Strong knowledge of global regulatory frameworks (FDA, EMA, PMDA and major emerging markets), policy development processes and regulatory science trends.
- Track record of cross-functional leadership, influencing senior stakeholders and representing an organization externally (industry groups, regulators).
- Experience with regulatory intelligence tools/platforms and with designing monitoring frameworks.
Director/Senior Director, Global Regulatory Policy & Intelligence in Maidenhead employer: Alnylam Pharmaceuticals
Contact Detail:
Alnylam Pharmaceuticals Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director/Senior Director, Global Regulatory Policy & Intelligence in Maidenhead
✨Tip Number 1
Network like a pro! Reach out to industry contacts on LinkedIn or at events. A friendly chat can lead to opportunities that aren’t even advertised yet.
✨Tip Number 2
Prepare for interviews by researching the company’s recent regulatory moves. Show them you’re not just interested in the role, but also in how you can contribute to their strategic goals.
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with their needs. Highlight your leadership skills and how you’ve successfully navigated regulatory challenges in the past.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Director/Senior Director, Global Regulatory Policy & Intelligence in Maidenhead
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Director/Senior Director role. Highlight your experience in regulatory policy and intelligence, and how it aligns with our needs at StudySmarter. We want to see how you can bring your unique skills to the table!
Showcase Your Leadership Skills: Since this role involves strategic leadership and team management, don’t forget to emphasise your experience in leading teams and driving initiatives. Share specific examples of how you've mentored others and shaped successful strategies in your previous roles.
Be Clear and Concise: When writing your application, clarity is key! Use straightforward language and get straight to the point. We appreciate well-structured applications that make it easy for us to see your qualifications and fit for the role.
Apply Through Our Website: We encourage you to submit your application through our website. It’s the best way for us to receive your details and ensures you’re considered for the position. Plus, it’s super easy to do!
How to prepare for a job interview at Alnylam Pharmaceuticals
✨Know Your Regulatory Landscape
Before the interview, dive deep into the current global regulatory frameworks, especially those relevant to the biopharma industry. Familiarise yourself with recent changes and trends in regulations from agencies like the FDA and EMA. This will not only show your expertise but also demonstrate your proactive approach to staying informed.
✨Showcase Your Leadership Skills
As a Director/Senior Director, you'll need to lead and mentor teams effectively. Prepare examples of how you've successfully built and managed teams in the past. Highlight specific KPIs you've set and achieved, and be ready to discuss how you align team deliverables with broader corporate goals.
✨Prepare for Cross-Functional Scenarios
This role requires collaboration across various functions. Think of instances where you've worked with teams like Legal, Market Access, or Commercial. Be ready to discuss how you’ve navigated differing priorities and ensured alignment in advocacy activities, as this will showcase your ability to integrate regulatory policy with business strategy.
✨Demonstrate Your Strategic Thinking
The interviewers will want to see your ability to anticipate and shape regulatory changes. Prepare to discuss how you've previously translated raw intelligence into actionable strategies. Bring examples of how your insights have influenced decision-making processes and led to successful outcomes in product development or lifecycle management.
