Associate Director Global Labeling
Alnylam Pharmaceuticals
9 hours ago
Remote friendly (United States)
United States
$170,900 - $231,300 USD yearly
Corporate Functions
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 health authority labeling legislation/guidelines on Alnylam products.
- 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 & Operations and Supply Chain to ensure submission-ready labeling components meet regulatory requirements; assist with health authority submissions as needed.
- Track data sources for labeling claims, labeling negotiation/history, and reasons for local labeling differences.
- Support the growth of the Global Labeling function and help design/build labeling 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/guidance.
- Up-to-date on emerging clinical/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.
- Strong written and verbal communication skills.
- 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 health authority labeling legislation/guidelines on Alnylam products.
- 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 & Operations and Supply Chain to ensure submission-ready labeling components meet regulatory requirements; assist with health authority submissions as needed.
- Track data sources for labeling claims, labeling negotiation/history, and reasons for local labeling differences.
- Support the growth of the Global Labeling function and help design/build labeling 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/guidance.
- Up-to-date on emerging clinical/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.
- Strong written and verbal communication skills.