Senior RA Specialist, Program Lead, EPNV

Job Summary

As Country Regulatory Affairs Lead, you coordinate regulatory activities across assigned markets, define and implement strategies for NPIs and LCM, manage submissions and post‑approval actions, and keep regulatory and labeling databases current. You lead RA specialists and external consultants, liaise with cross‑functional teams and franchises, represent J&J to health authorities, and monitor regulatory changes to ensure compliant, timely product approvals.

Responsibilities

• Coordinate regulatory activities in the country (or group of countries) under scope.
• Determine regulatory strategy for NPIs (New Products Introduction) and LCM (Life Cycle Management).
• Execute submissions for new registrations, changes and renewals.
• Drive post‑approval activities.
• Liaise with cross‑functional partners.
• Coordinate the work of RA specialists to ensure seamless business plan execution.