Associate Director, Global Labeling
Alnylam Pharmaceuticals
August 30, 2026
Remote friendly (Cambridge, MA)
United States
Operations
Key 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.
- Provide strategic guidance on labeling regulations, competitor labeling, and labeling trends.
- Review and communicate impact of health authority labeling legislation/guidelines on Alnylam products.
- Develop and maintain regional labeling aligned with CCDS and health authority requirements.
- Prepare responses to labeling-related queries from health authorities.
- Coordinate labeling activities (e.g., labeling supplements, new labeling development) with internal/external alliance partners.
- Partner with Regulatory Technology and Operations and Supply Chain to ensure submission-ready labeling components comply with regulatory requirements; assist with submissions as needed.
- Track data sources supporting labeling claims and reasons for differences in local labeling.
- Support growth of the Global Labeling function; design/build systems and processes.
Qualifications:
- BS/BA in science or related discipline (graduate degree desirable).
- Biopharmaceutical industry experience in Regulatory Affairs, Pharmacovigilance, and/or Medical Writing/Communications.
- At least 2 years in a Regulatory Affairs Labeling role developing/drafting prescribing information.
- Familiarity with US, EU, and global labeling regulations, standards, and guidance.
- Ability to stay current on clinical/product safety/manufacturing changes and post-marketing commitments affecting CCDS/local labeling.
- Detail-oriented, able to multi-task and manage multiple projects.
- Strong written and verbal communication skills.
Benefits (as stated): Medical/dental/vision, life/disability, lifestyle reimbursement, flexible spending/HSAs, 401(k) match, paid time off, wellness days, holidays, recharge breaks, family resources/leave.
Location: Hybrid in Cambridge, MA or Philadelphia, PA.
- 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.
- Provide strategic guidance on labeling regulations, competitor labeling, and labeling trends.
- Review and communicate impact of health authority labeling legislation/guidelines on Alnylam products.
- Develop and maintain regional labeling aligned with CCDS and health authority requirements.
- Prepare responses to labeling-related queries from health authorities.
- Coordinate labeling activities (e.g., labeling supplements, new labeling development) with internal/external alliance partners.
- Partner with Regulatory Technology and Operations and Supply Chain to ensure submission-ready labeling components comply with regulatory requirements; assist with submissions as needed.
- Track data sources supporting labeling claims and reasons for differences in local labeling.
- Support growth of the Global Labeling function; design/build systems and processes.
Qualifications:
- BS/BA in science or related discipline (graduate degree desirable).
- Biopharmaceutical industry experience in Regulatory Affairs, Pharmacovigilance, and/or Medical Writing/Communications.
- At least 2 years in a Regulatory Affairs Labeling role developing/drafting prescribing information.
- Familiarity with US, EU, and global labeling regulations, standards, and guidance.
- Ability to stay current on clinical/product safety/manufacturing changes and post-marketing commitments affecting CCDS/local labeling.
- Detail-oriented, able to multi-task and manage multiple projects.
- Strong written and verbal communication skills.
Benefits (as stated): Medical/dental/vision, life/disability, lifestyle reimbursement, flexible spending/HSAs, 401(k) match, paid time off, wellness days, holidays, recharge breaks, family resources/leave.
Location: Hybrid in Cambridge, MA or Philadelphia, PA.