Manager, Regulatory Affairs Strategic Labeling
The Manager Labeling Regulatory Affairs Strategic Labeling, develops and maintains US/EU package inserts and Company Core Data Sheets and coordinates review and approval of these documents with changing regulatory environments. Leads discussions to ensure global consistency of labeling. Educates team members concerning global consistency of labeling.
Key Responsibilities Include:
Key Responsibilities Include:
- Leads teams on labeling decisions based on knowledge of processes and regulations. Educates others as to new labeling regulations regarding Company core Data Sheet (CCDS), US Package Insert (USPI), Summary of Product Characteristics (SmPC), Structured Product Labeling (SPL) , or Instructions for Use ( IFUs).
- Reviews and assesses data to determine whether accurate and reproducible. Works with clinical and safety teams to assure revised data is included as support documentation following approvals. Provides labeling input for Risk Management Plans, Regulatory Strategic & Tactical Plans (RSTPs) and safety documents.
- Drives strategic labeling processes within teams based on knowledge of success with other products. Makes recommendations to proactively optimize label language, including effective use of Target Product Label (TPL) and Development Core Data Sheets (DCDS) as applicable, for assigned products.
- Maintains accurate files of labeling change history and associated documents, including annotations to data sources.
- Participates at team meetings, reviews materials, authors documents and meets timelines. Leads cross-functional teams to resolve labeling issues and address Ministry of Health (MOH) requests globally.
- Works with safety groups on safety issues and leads discussion on safety related labeling changes. Makes decisions on own topics and those of direct reports based on experience with various products. Understands and supports regulatory implications of product profile.
- Works strategically with Research and Development (R&D), Global Medical Affairs and safety to maintain accurate safety profiles for assigned products.
- Works with Labeling Operations to ensure quality documents are internally maintained or submitted to FDA.
- Provides labeling support to Asset Development Team (ADTs) and affiliates including pre-approvals, renewals, and competitive analysis.
- May indirectly manage work of other department members. Assists in training of new personnel and in the development of department processes/policies.
- Required Education: Bachelor's degree in Pharmacy, Biology, Chemistry, pharmacology or related subject
- Preferred Education: Bachelor's degree. Certifications a plus
- Required Experience: 6 years in Pharmaceutical, regulatory, R&D or industry related area. Experience in labeling or area that could link to labeling
- Ability to supervise projects and set daily priorities. Able to work in a complex and matrix environment
- Preferred Experience: 3 years in pharmaceutical or regulatory preferred. Minimum 3 years' experience in clinical or pharmaceutical preferred
- Cross-divisional team experience and working with cross-functional teams.
- Strong problem solving with minimal guidance
- Note: Higher education may compensate for years of experience