Global Regulatory Affairs CMC Manager (m/w/d)
Skills: Regulatory Affairs, CMC, Module 3
- Responsible for operational regulatory CMC activities such as:
- Coordination, preparation and review of regulatory submission packages related to CMC submissions and Health Authority responses for the Gene Therapy portfolio.
- Supports scheduling and prioritization of CMC related submissions.
- Responsible for the compilation and maintenance of CMC documentation/CTD for regulatory submissions and cooperation with relevant technical expert departments in cross-functional teams.
- Responsible for regulatory CMC documents/CTD documentation formatting and maintenance within document management system, maintenance of relevant regulatory lists and tracking documents.
- Provision or support of timely and compliant regulatory assessments, as well as efficient execution of CMC changes.
- Evaluates available technical and scientific CMC information for compliance with regulatory requirements, performs gap analysis and proposes solutions and strategies to remediate risks.
- 1-3 years working experience within the field of Global RA
- Experience in CMC variations, dossier compiling and submissions
- PhD is welcome