Position Overview
Your newpany
Are you an experienced Regulatory Affairs professional looking to take ownership of life cycle strategy across a dynamic EMEA portfolio? Weβre partnering with a leading healthcare organisation to find a Regulatory Affairs Consultant, life cycle management, to join their growing team.This is a fantastic opportunity to play a key strategic and operational role across product life cycle management, working at the intersection of CMC, regulatory strategy, and cross-functional collaboration. Youβll contribute to both innovation and maintenance of existing products while managing a small team.
Your new role
Key Responsibilities
Lifecycle Management & Submissions
Lead end-to-end lifecycle management activities including variations, renewals, labelling updates, and aggregate reportsPrepare and submit variation applications via EU procedures (MRP/DCP, Workshare), includingplex submissions and super-groupings.Develop submissi...