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) in collaboration with Global Regulatory Leads and Core Labeling Teams (CLTs).
- Develop labeling strategies and Target Label Profiles.
- Provide strategic guidance to Core Labeling Teams on new/revised labeling regulations, competitor labeling, and labeling trends.
- Review and communicate 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 comply with regulatory requirements; assist with health authority submissions as needed.
- Track data sources supporting labeling claims and document labeling history, negotiation changes, and reasons for local differences.
- Support growth of the Global Labeling function; help design/build systems and processes.

Qualifications:
- BS/BA in science or related field (graduate degree desirable).
- Biopharmaceutical industry experience in Regulatory Affairs, Pharmacovigilance, and/or Medical Writing/Communications.
- Regulatory Affairs experience, including at least 2 years in a Labeling role responsible for developing/drafting prescribing information.
- Familiarity with US, EU, and Global pharmaceutical labeling regulations, standards, and guidance.
- Detail-oriented; able to multi-task and manage multiple projects.
- Skilled in written and verbal communications.