Director, Regulatory Affairs, Global Labeling Strategy

• BS/BA degree (science or related discipline preferred), graduate degree desirable.
• Minimum of 12 years of professional experience in biopharmaceutical industry in fields of Regulatory Affairs, Pharmacovigilance, and/or Medical Writing/Communications.
• Minimum of 7-8 years of experience in Regulatory Affairs, including at least 5 years of experience in labeling strategy.
• Thorough knowledge of US, EU and Global regulations, standards and guidance documents related to labeling of pharmaceutical products.
• Demonstrated ability to create and gain approval for labeling strategies that connect the target claim to study design, endpoint selection, analysis, and the evidence package.
• Strong strategic judgment and creativity: able to move beyond describing precedents to formulate new, credible, and differentiated approaches.
• Ability to synthetize regulatory intelligence, literature research, competitor analysis, and data to generate actionable recommendations.
• Curiosity and practical experience with AI-enabled research and productivity tools, combined with disciplined source verification, protection of confidential information, and accountable human oversight.
• Track record of influencing cross-functional teams, constructively challenging assumptions, and communicating strategic choices to senior stakeholders.
• Excellent drafting, facilitation, negotiation, and written and verbal communication skills.
• Highly organized and detail-oriented, with the ability to manage multiple complex programs and balance strategic ambition with executional rigor.
• Highly motivated to work independently and represent the position of Global labeling.
• Ability to remain current on emerging clinical and safety data, manufacturing changes, post-marketing commitments, and regulatory developments that may affect the CCDS or regional and local labeling.
• Track record in developing and maintaining Target Label Profiles, Company Core Data Sheets, Standard Operating Procedures (SOPs) and Work Instructions, and managing or coordinating core labeling activities.
• Prior experience managing a team desirable.

Summary of Key Responsibilities

1. 1Lead Alnylam’s US Labeling function whilst forming part of the Global Labeling team in Regulatory Affairs, and build new, scalable capabilities and processes to support Alnylam’s growth as a commercial organization.
2. 2Strong scientific background in different disease areas working across multiple therapy areas, with a focus on the interpretation of data and the strategic implications for labeling.
3. 3Ensure the implementation of differentiated global labeling strategies and Target Label Profiles that articulate the intended product value, priority claims, evidence requirements, risks, and negotiation pathways.
4. 4Translate strategic labeling ambitions into actionable evidence plans by partnering early with Clinical Development, Biostatistics, Medical, Safety, Regulatory, and Market Access teams.
5. 5Influence study design and endpoint selection by identifying the primary, secondary, exploratory, patient-relevant, and other evidence elements required to support compelling and defensible labeling claims.
6. 6Drive and implement novel labeling options by synthesizing regulatory precedents, competitor positioning, health authority decisions, scientific literature, clinical practice, and evolving policy. Precedent analysis is an input, not the endpoint.
7. 7Use approved AI tools and advanced research approaches responsibly to accelerate intelligence gathering, identify patterns and evidence gaps, stress-test strategic options, and improve the quality and speed of labeling recommendations. Apply expert review, source verification, confidentiality controls, and regulatory judgment to all AI-supported outputs.
8. 8Lead the development of scenario-based claim strategies, including ambitious, target, and fallback positions, with clear evidence thresholds, trade-offs, and negotiation plans for key regions.
9. 9Represent Global Labeling (GL) including US Labeling on Regulatory Affairs governance forums and other cross-functional product, development, and product safety teams as appropriate.
10. 10Develop and provide strategic guidance on emerging labeling regulations, health authority expectations, competitor labels, labeling trends, and implications for the development portfolio and marketed products.
11. 11Lead regional labeling development aligned with the CCDS and tailored to health authority requirements, local evidence expectations, and the global negotiation strategy.
12. 12Lead and oversee preparation of labeling briefing materials and responses to health authority questions, and support negotiations with robust evidence-based arguments and well-developed fallback positions.
13. 13Coordinate labeling activities with internal and external alliance partners and align stakeholders around strategic objectives, decision points, and accountabilities.
14. 14Partner with Labeling Operations, Regulatory Technology and Operations, and Supply Chain to ensure submission-ready labeling components comply with regulatory requirements. Assist with preparation of submissions to health authorities, as needed.
15. 15Effectively plan for, hire, on-board, and mentor Regulatory Labeling Strategy team as company grows.
16. 16Support the growth of the Global Labeling function and help design/build systems and processes.