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) β 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.