Associate Director, Global Labeling

Associate Director, Global Labeling

Alnylam is seeking an experienced labeling professional to join our labeling strategy team. This team is responsible for developing initial product label content and strategy through the Target Label Process (TLP). The ideal candidate will possess expertise in drafting label content and leading cross-functional teams within a larger development framework. In this role, you will work closely with labeling operations, compliance teams, and various internal stakeholders.

Key Responsibilities:

• Represent Global Labeling on product-specific Global Regulatory Teams and other cross-functional product, development, and product safety teams as appropriate.
• In collaboration with Global Regulatory Leads and Core Labeling Teams (CLTs): create, revise, and maintain Company Core Data Sheets (CCDS) for Alnylam's products.
• Develop labeling strategies and Target Label Profiles.
• Provide strategic guidance to Core Labeling Teams regarding new and revised labeling regulations, competitor labeling, and labeling trends.
• Review and communicate impact of changes in health authority labeling legislation or guidelines on Alnylam's products.
• Lead with development and maintenance of regional labeling that aligns with the CCDS and meets the requirements of health authorities.
• Lead with preparation of responses to labeling-related queries from health authorities.
• Coordinate labeling activities (e.g., labeling supplements, new labeling development) with internal and external alliance partners as required.
• Partner with 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.
• Track data sources supporting labeling claims, history of labeling negotiations and changes, and reasons for differences in local labeling.
• 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.
• Professional experience in biopharmaceutical industry in fields of Regulatory Affairs, Pharmacovigilance, and/or Medical Writing/Communications.
• Experience in Regulatory Affairs, including at least 2 years' experience in a Labeling role responsible for developing and drafting prescribing information content.
• Familiarity with US, EU and Global regulations, standards and guidance documents related to labeling of pharmaceutical products.
• Must be detail-oriented and able to multi-task and manage multiple projects.
• Skilled in written and verbal communications.

U.S. Pay Range $ - $

About Alnylam:

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. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law.

Alnylam is an E-Verify Employer.