Senior Regulatory Affairs Consultant - Labelling Strategy (home or office based)

Experteer Overview

In this role you will be the principal labeling strategist within Global Regulatory Affairs, driving labeling strategy and the creation and upkeep of CCDS, dCCDS, USPI, and EU SmPC for the product portfolio. You will align labeling with regulatory, registration, and development plans while supporting early development and cross-functional teams. You’ll lead global labeling discussions, ensure consistency across CCDS and product labels, and represent Global Labeling in strategy forums. This position offers a hybrid setup and the chance to influence labeling standards at a global scale.

Retribuzione / Benefits

• Generate and maintain dCCDS, CCDS, USPI, and EU SmPC as assigned
• Deliver labeling strategy for early development to inform claims
• Contribute labeling perspective to Clinical Study designs, Protocols, and Briefing Books
• Lead interactions with SMEs (GCSP, GCD, GRA, CDO) for dCCDS/CCDS labeling
• Collaborate on USPI and EU SmPC reviews with regional leads
• Communicate updates to Global Labeling Operation Managers and regions
• Lead assessment of exceptions between CCDS and USPI/SmPC via Global Labeling Committee processes
• Escalate compliance issues to Director, Global Labeling Strategy
• Represent Global Labeling in GRA Strategy Teams and TA teams
• Stay up to date with global labeling requirements
• Represent Global Labeling in internal and external meetings
• Build cross-functional networks within GRA, R&D, and Commercial Development

Responsabilità

• University degree in Life Sciences or related Pharmaceutical field
• Minimum of 10 years in biotech/pharmaceutical industry with at least 6 years in labeling/regulatory experience
• Knowledge of regulatory principles related to drug development, global labeling, and post-marketing requirements
• Strong scientific background with ability to translate scientific content into labeling
• Proven problem‑solving ability and risk assessment skills
• Proficient regulatory and drug/biologic development knowledge from pre‑clinical to post‑clinical
• Effective communication skills for diverse audiences on complex concepts
• Attention to detail with strategic thinking
• Fluency in English (verbal and written)