Director, Regulatory Affairs, Global Labeling Strategy (US)

Job description

Director, Regulatory Affairs, Global Labeling Strategy (US) Overview The Director of Global Labeling (GL) US will play a lead role in building and refining Alnylam’s global labeling strategy processes and capabilities; supervise junior labeling strategists and provide strategic guidance in the development and maintenance of Company Core Data Sheets (CCDS), country product information (CPI) for Alnylam’s products, and development of Target Label Profiles (TLP) for investigational therapies or uses. Summary of Key Responsibilities Lead 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. Strong 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. Ensure 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. Translate strategic labeling ambitions into actionable evidence plans by partnering early with Clinical Development, Biostatistics, Medical, Safety, Regulatory, and Market Access teams. Influence 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. Drive 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. Use 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. Lead 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. Represent Global Labeling (GL) including US Labeling on Regulatory Affairs governance forums and other cross-functional product, development, and product safety teams as appropriate. Develop and provide strategic guidance on emerging labeling regulations, health authority expectations, competitor labels, labeling trends, and implications for the development portfolio and marketed products. Lead regional labeling development aligned with the CCDS and tailored to health authority requirements, local evidence expectations, and the global negotiation strategy. Lead 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. Coordinate labeling activities with internal and external alliance partners and align stakeholders around strategic objectives, decision points, and accountabilities. Partner 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. Effectively plan for, hire, on-board, and mentor Regulatory Labeling Strategy team as company grows. Support the growth of the Global Labeling function and help design/build systems and processes. Qualifications 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 approva