Manager, Labeling Regulatory Affairs Strategic Labeling

Role Summary

The Manager, Labeling Regulatory Affairs – Strategic Labeling leads development and maintenance of US/EU package inserts and Company Core Data Sheets, coordinating review and approval amidst changing regulatory environments. The role ensures global consistency of labeling and educates team members on labeling standards. The position collaborates with R&D, Global Medical Affairs and safety to maintain accurate safety profiles and compliant labeling across products.

Responsibilities

• Leads teams on labeling decisions based on knowledge of processes and regulations. Educates others as to new labeling regulations regarding CCDS, USPI, SmPC, SPL, or 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 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 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.

Qualifications

• 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

Additional Requirements

• Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required