Associate Director, Global Labeling
Alnylam Pharmaceuticals
August 08, 2026
Remote friendly (Cambridge, MA)
United States
Corporate Functions
Overview / Responsibilities:
- Represent Global Labeling on product-specific Global Regulatory Teams and other cross-functional product, development, and product safety teams.
- Create, revise, and maintain Company Core Data Sheets (CCDS) with Global Regulatory Leads and Core Labeling Teams (CLTs).
- Develop labeling strategies and Target Label Profiles.
- Advise Core Labeling Teams on new/revised labeling regulations, competitor labeling, and labeling trends.
- Review and communicate impacts of health authority labeling legislation/guidelines on Alnylam products.
- Develop and maintain regional labeling aligned with CCDS and health authority requirements.
- Prepare responses to health authority labeling queries.
- Coordinate labeling activities (e.g., supplements, new labeling development) with internal/external alliance partners.
- Partner with Regulatory Technology and Operations and Supply Chain to ensure submission-ready labeling components; assist with submissions as needed.
- Track sources for labeling claims, labeling history/negotiations, and reasons for local differences.
- Support growth of Global Labeling; help design/build systems and processes.
Qualifications:
- BS/BA (science or related preferred); graduate degree desirable.
- Biopharmaceutical industry experience in Regulatory Affairs, Pharmacovigilance, and/or Medical Writing/Communications.
- Regulatory Affairs experience, including 2+ years in a Labeling role drafting prescribing information.
- Knowledge of US/EU/global pharmaceutical labeling regulations/standards/guidance.
- Ability to stay current on clinical/safety/manufacturing and post-marketing changes affecting CCDS/local/regional labeling.
- Detail-oriented; able to multi-task and manage multiple projects; strong written/verbal communication.
Hybrid: Cambridge, MA or Philadelphia, PA.
Comp/Benefits (as stated): $170,900.00–$231,300.00 base; eligible for short-term and long-term incentives; medical/dental/vision, life/disability, 401(k), paid time off, wellness days, holidays, and recharge breaks.
Learn more: https://www.alnylam.com/careers
- Represent Global Labeling on product-specific Global Regulatory Teams and other cross-functional product, development, and product safety teams.
- Create, revise, and maintain Company Core Data Sheets (CCDS) with Global Regulatory Leads and Core Labeling Teams (CLTs).
- Develop labeling strategies and Target Label Profiles.
- Advise Core Labeling Teams on new/revised labeling regulations, competitor labeling, and labeling trends.
- Review and communicate impacts of health authority labeling legislation/guidelines on Alnylam products.
- Develop and maintain regional labeling aligned with CCDS and health authority requirements.
- Prepare responses to health authority labeling queries.
- Coordinate labeling activities (e.g., supplements, new labeling development) with internal/external alliance partners.
- Partner with Regulatory Technology and Operations and Supply Chain to ensure submission-ready labeling components; assist with submissions as needed.
- Track sources for labeling claims, labeling history/negotiations, and reasons for local differences.
- Support growth of Global Labeling; help design/build systems and processes.
Qualifications:
- BS/BA (science or related preferred); graduate degree desirable.
- Biopharmaceutical industry experience in Regulatory Affairs, Pharmacovigilance, and/or Medical Writing/Communications.
- Regulatory Affairs experience, including 2+ years in a Labeling role drafting prescribing information.
- Knowledge of US/EU/global pharmaceutical labeling regulations/standards/guidance.
- Ability to stay current on clinical/safety/manufacturing and post-marketing changes affecting CCDS/local/regional labeling.
- Detail-oriented; able to multi-task and manage multiple projects; strong written/verbal communication.
Hybrid: Cambridge, MA or Philadelphia, PA.
Comp/Benefits (as stated): $170,900.00–$231,300.00 base; eligible for short-term and long-term incentives; medical/dental/vision, life/disability, 401(k), paid time off, wellness days, holidays, and recharge breaks.
Learn more: https://www.alnylam.com/careers