Associate Director, Global Labeling

Overview

Alnylam is seeking an experienced labeling professional to join our labeling strategy team. This team develops initial product label content and strategy through the Target Label Process (TLP). The ideal candidate will have expertise in drafting label content and leading cross-functional teams within a larger development framework, working closely with labeling operations, compliance teams, and internal stakeholders.

• Represent Global Labeling on product-specific Global Regulatory Teams and other cross-functional product development and product safety teams as appropriate.
• Collaborate with Global Regulatory Leads and Core Labeling Teams (CLTs) to create, revise, and maintain Company Core Data Sheets (CCDS) for Alnylam 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 the impact of changes in health authority labeling legislation or guidelines on Alnylam products.
• Lead development and maintenance of regional labeling that aligns with the CCDS and meets health authority requirements.
• Lead the preparation of responses to labeling-related queries from health authorities.
• Coordinate labeling activities with internal and external alliance partners as required (e.g., labeling supplements, new labeling development).
• Partner with Regulatory Technology, 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 assist in designing/building systems and processes.

This role is hybrid in either Cambridge, MA or Philadelphia, PA.

• BS/BA degree (science or related discipline preferred); graduate degree desirable.
• Professional experience in biopharmaceuticals in Regulatory Affairs, Pharmacovigilance, and/or Medical Writing/Communications.
• Experience in Regulatory Affairs with at least 2 years in a labeling role responsible for developing and drafting prescribing information content.
• Familiarity with US, EU and Global labeling regulations, standards, and guidance documents.
• Ability to stay up to date on emerging clinical and other data, product safety, manufacturing changes, and post-marketing commitments that may trigger CCDS or regional/local labeling changes.
• Detail-oriented with ability to multi-task and manage multiple projects.
• Skilled in written and verbal communications.

$ - $

The pay range reflects the full-time base salary for this role at the time of posting. Base pay will be determined based on factors including relevant experience, skills, and education. This role is eligible for annual incentives and equity awards.

Alnylam offers a comprehensive Total Rewards package designed to support health and well-being, including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts, a 401(k) with company match, paid time off, wellness days, holidays, recharge breaks, family resources, and leave. Our commitment is to a people-first culture that fuels our impact.

Learn more about these and additional benefits on the Careers Benefits section:

We are a leader in RNAi therapeutics—a transformative approach with the potential to improve lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has driven breakthroughs in RNAi therapeutics. Our 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 are a globally recognized employer with an authentic, inclusive culture and breakthrough thinking fueling one another.

Alnylam is an equal employment opportunity employer. Qualified applicants will receive consideration without regard to sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, disability, pregnancy, genetic information, veteran status, marital status, political affiliation, age, or any other factor protected by law. Alnylam participates in E-Verify.