Associate Director, Global Labeling
Alnylam Pharmaceuticals
2 months ago
Remote friendly (Cambridge, MA)
United States
$170,900 - $231,300 USD yearly
Operations
Key Responsibilities:
- Represent Global Labeling on product-specific Global Regulatory Teams and other cross-functional product, development, and product safety teams.
- 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 the impact of changes in health authority labeling legislation or guidelines.
- Lead development and maintenance of regional labeling aligned with the 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 meet regulatory requirements; assist with submissions as needed.
- Track data sources for labeling claims, labeling history/negotiations, and reasons for differences in local labeling.
- Support growth of the Global Labeling function; design/build systems and processes.
Qualifications:
- BS/BA degree (science or related discipline preferred); graduate degree desirable.
- Professional experience in biopharmaceutical industry in Regulatory Affairs, Pharmacovigilance, and/or Medical Writing/Communications.
- Regulatory Affairs experience, including at least 2 years in a Labeling role responsible for developing and drafting prescribing information content.
- Familiarity with US, EU, and global regulations, standards, and guidance for pharmaceutical product labeling.
- Stay current on emerging clinical/data, product safety, manufacturing changes, and post-marketing commitments/requirements affecting CCDS and regional/local labeling.
- Detail-oriented; able to multitask and manage multiple projects.
- Skilled in written and verbal communications.
- Represent Global Labeling on product-specific Global Regulatory Teams and other cross-functional product, development, and product safety teams.
- 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 the impact of changes in health authority labeling legislation or guidelines.
- Lead development and maintenance of regional labeling aligned with the 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 meet regulatory requirements; assist with submissions as needed.
- Track data sources for labeling claims, labeling history/negotiations, and reasons for differences in local labeling.
- Support growth of the Global Labeling function; design/build systems and processes.
Qualifications:
- BS/BA degree (science or related discipline preferred); graduate degree desirable.
- Professional experience in biopharmaceutical industry in Regulatory Affairs, Pharmacovigilance, and/or Medical Writing/Communications.
- Regulatory Affairs experience, including at least 2 years in a Labeling role responsible for developing and drafting prescribing information content.
- Familiarity with US, EU, and global regulations, standards, and guidance for pharmaceutical product labeling.
- Stay current on emerging clinical/data, product safety, manufacturing changes, and post-marketing commitments/requirements affecting CCDS and regional/local labeling.
- Detail-oriented; able to multitask and manage multiple projects.
- Skilled in written and verbal communications.