Associate Director, Global Labeling
Alnylam Pharmaceuticals
August 29, 2026
Remote friendly (Philadelphia, PA)
United States
Corporate Functions
Key Responsibilities:
- 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).
- Develop labeling strategies and Target Label Profiles.
- Provide strategic guidance on new/revised labeling regulations, competitor labeling, and labeling trends.
- Review and communicate impact of health authority labeling legislation/guidelines changes on Alnylam products.
- Lead development and maintenance of 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 and 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, labeling negotiation history, and reasons for differences in local labeling.
- Support growth of the Global Labeling function by designing/building 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 Labeling role within Regulatory Affairs, responsible for developing/drafting prescribing information content.
- Familiarity with US, EU, and global pharmaceutical labeling regulations, standards, and guidance.
- Keep up to date on emerging clinical data, product safety, manufacturing changes, and post-marketing commitments affecting CCDS/regional labeling.
- Detail-oriented; able to multitask and manage multiple projects.
- Strong written and verbal communication.
Work Location:
- Hybrid (Cambridge, MA or Philadelphia, PA).
- 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).
- Develop labeling strategies and Target Label Profiles.
- Provide strategic guidance on new/revised labeling regulations, competitor labeling, and labeling trends.
- Review and communicate impact of health authority labeling legislation/guidelines changes on Alnylam products.
- Lead development and maintenance of 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 and 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, labeling negotiation history, and reasons for differences in local labeling.
- Support growth of the Global Labeling function by designing/building 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 Labeling role within Regulatory Affairs, responsible for developing/drafting prescribing information content.
- Familiarity with US, EU, and global pharmaceutical labeling regulations, standards, and guidance.
- Keep up to date on emerging clinical data, product safety, manufacturing changes, and post-marketing commitments affecting CCDS/regional labeling.
- Detail-oriented; able to multitask and manage multiple projects.
- Strong written and verbal communication.
Work Location:
- Hybrid (Cambridge, MA or Philadelphia, PA).