Senior CMC Regulatory Leader (EMEA) – Submissions & Lifecycle

Senior CMC Regulatory Leader (EMEA) – Submissions & Lifecycle

Full-Time On-site
Planet Pharma Group

Planet Pharma is seeking an Associate Director/Senior Manager, CMC Regulatory to shape regulatory strategy for development and post-approval lifecycle of small-molecule products in the EMEA region with Japan and US coordination.

You will lead preparation and review of CTD Module 3 dossiers, engage with Health Authorities, and ensure CMC quality and compliance across projects, with a focus on timing, risk management and cross-functional teamwork.

Senior CMC Regulatory Leader (EMEA) – Submissions & Lifecycle employer: Planet Pharma Group

Planet Pharma Group is an exceptional employer that fosters a dynamic and inclusive work culture, where innovation in healthcare technology thrives. Employees benefit from flexible hybrid working arrangements, comprehensive professional development opportunities, and a commitment to enhancing patient care, making it a rewarding place to grow your career while making a meaningful impact in the industry.

Planet Pharma Group

Contact Details:

Planet Pharma Group Recruitment Team