Job Description
Your new company
Are you an experienced Regulatory Affairs professional looking to take ownership of lifecycle strategy across a dynamic EMEA portfolio? We're partnering with a leading healthcare organisation to find a Regulatory Affairs Consultant - LCM to join their growing team.
This is a fantastic opportunity to play a key strategic and operational role across product lifecycle management, working at the intersection of CMC, regulatory strategy, and cross-functional collaboration. You'll 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 reports
Prepare and submit variation applications via EU procedures (MRP/DCP, Workshare), including complex submissions and super-groupings.
Develop submission strategies, including refe...
Are you an experienced Regulatory Affairs professional looking to take ownership of lifecycle strategy across a dynamic EMEA portfolio? We're partnering with a leading healthcare organisation to find a Regulatory Affairs Consultant - LCM to join their growing team.
This is a fantastic opportunity to play a key strategic and operational role across product lifecycle management, working at the intersection of CMC, regulatory strategy, and cross-functional collaboration. You'll 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 reports
Prepare and submit variation applications via EU procedures (MRP/DCP, Workshare), including complex submissions and super-groupings.
Develop submission strategies, including refe...