Associate Director, Regulatory Labeling Strategy

Education/Experience Requirements

• Bachelor's degree in a scientific discipline such as Biology, Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field required. Equivalent combination of education and applicable job experience may be considered
• Advanced degree (MS, PhD, PharmD, or equivalent) in related discipline preferred.
• 8+ years of relevant pharmaceutical or biotech industry experience. Including 6 years of direct labeling experience or combination of 5+ years regulatory and related experience.
• Strong knowledge of US and EU product labeling requirements, regulations, and guidelines (USPI and EU SmPC experience required).

1. 1Independently leads Labeling multi-disciplinary team (Labeling Working Group - LWG) driving cross-functional collaboration to gain alignment on labeling strategy and labeling content.
2. 2Coordinates the process to obtain labeling approval by Executive Labeling Board (ELB), as applicable to the review and approval process.
3. 3Authors new/revised TPL, CCDS, and USPI for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations/supporting documents.
4. 4Develops and executes a global labeling implementation plans to incorporate new scientific, safety and clinical data, as well as Health Authority responses into CCDS/USPI enabling the most current information and in compliance with labeling requirements Health Care Providers and patients.
5. 5Independently authors and manages communications regarding CCDS and labeling updates for assigned products.
6. 6Demonstrates strong project management skills to coordinate global labeling functions to ensure timely Health Authority submission and key role in label negotiations with Health Authorities.
7. 7Interprets regulations and guidance documents relevant to the development and implementation of labeling documents and assures labeling content and processes conform to regulatory requirements.
8. 8Manages process for alignment of local labeling with CCDS for assigned products, including assessment of labeling deviations in US, EU, and ROW.
9. 9Provides strategic direction and subject-matter guidance to Local Labeling Leads for responses to health authorities’ requests/labeling negotiations.
10. 10Appropriately presents issues and seeks endorsement from Executive Labeling Board for proposed risk mitigation strategies, labeling negotiations strategies, and other important/major labeling updates for assigned products.
11. 11Conducts precedent, analyzes relevant competitor labeling, assesses labeling guidance and trends, and develops labeling strategies and language for assigned product labels (TPL, CCDS, USPI) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure the most competitive labeling possible.
12. 12Represents Global Labeling at Regulatory Satellite, Regulatory Product Strategy, business partner meetings, and other initiatives.
13. 13Provides regulatory input for the development and revision of carton and container artwork. Collaborate with Technical Operations to implement approved labeling into packaging.
14. 14Supports Health Authority Inspections by providing labeling information requests related to assigned products and overall labeling processes.
15. 15Manages the Structured Product Label (SPL) process; collaborates with external vendors, ensures SPL is acceptable for submission, and confirms successful submission with Regulatory Operations.
16. 16Lead and actively contribute to the continuous improvement of labeling processes, identifying opportunities for optimization to enhance efficiency.
17. 17Additional duties assigned as needed.