Associate Director, Global Labeling

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) for Alnylam’s products with Global Regulatory Leads and Core Labeling Teams (CLTs).
- 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 changes in health authority labeling legislation/guidelines.
- Lead regional labeling development/maintenance aligned with the CCDS and health authority requirements.
- Prepare responses to labeling-related queries from health authorities.
- 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 comply with regulatory requirements; assist with submissions as needed.
- Track data sources supporting labeling claims and document labeling history and reasons for local differences.
- Support growth of the Global Labeling function; 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.
- At least 2 years in a Labeling role within Regulatory Affairs, including drafting prescribing information content.
- Familiarity with US, EU, and global pharmaceutical labeling regulations/standards/guidance.
- Ability to stay current on emerging data, product safety, manufacturing changes, and post-marketing commitments affecting CCDS and regional/local labeling.
- Detail-oriented; able to multi-task and manage multiple projects.
- Skilled in written and verbal communication.

Hybrid role: Cambridge, MA or Philadelphia, PA