[Hiring] Director, Regulatory Affairs, Global Labeling Strategy @Alnylam Pharmaceuticals

Role Description

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.

• Lead Alnylam’s US Labeling function as part of the Global Labeling team in Regulatory Affairs.
• Build new, scalable capabilities and processes to support Alnylam’s growth as a commercial organization.
• Ensure implementation of differentiated global labeling strategies and Target Label Profiles.
• Translate strategic labeling ambitions into actionable evidence plans by partnering early with various teams.
• Influence study design and endpoint selection by identifying necessary evidence elements.
• Drive and implement novel labeling options by synthesizing various inputs.
• Use approved AI tools and advanced research approaches responsibly to enhance labeling recommendations.
• Lead the development of scenario-based claim strategies with clear evidence thresholds.
• Represent Global Labeling on Regulatory Affairs governance forums and cross-functional teams.
• Develop and provide strategic guidance on emerging labeling regulations and trends.
• Lead regional labeling development aligned with CCDS and tailored to health authority requirements.
• Oversee preparation of labeling briefing materials and responses to health authority questions.
• Coordinate labeling activities with internal and external alliance partners.
• Partner with various teams to ensure submission-ready labeling components comply with regulatory requirements.
• Effectively plan for, hire, on-board, and mentor the Regulatory Labeling Strategy team.
• 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 in labeling strategy.
• Thorough knowledge of US, EU and Global regulations related to labeling of pharmaceutical products.
• Demonstrated ability to create and gain approval for labeling strategies.
• Strong strategic judgment and creativity.
• Ability to synthesize regulatory intelligence and generate actionable recommendations.
• Curiosity and practical experience with AI-enabled research tools.
• Track record of influencing cross-functional teams and communicating strategic choices.
• Excellent drafting, facilitation, negotiation, and communication skills.
• Highly organized and detail-oriented.
• Highly motivated to work independently and represent the position of Global labeling.
• Ability to remain current on emerging clinical and safety data and regulatory developments.
• Track record in developing and maintaining Target Label Profiles and managing core labeling activities.
• Prior experience managing a team desirable.

Company Description

We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity.