Regulatory CMC Compliance Manager
My client, a producer of global vaccines and diagnostics are looking for a CMC and Compliance Manager to join their vaccines headquarters in Italy. This is a great opportunity to work for a leading, global pharmaceutical company.
- Prepare CMC (Quality) documentation for new Clinical Trial Applications, IND (Investigational New Drug) submissions and amendments, CTD (Common Technical Document) submissions and subsequent variations.
- Write and edit Module 2 and Module 3 documents in accordance with CTD guidance and company standards.
- Write and edit CMC related IND and IMPD (Investigational Medicinal Product Dossier) documentation and health authorities’ communication packages.
- Interact with Regulatory Authorities and provide them responses to comments and questions.
- Provide CMC related regulatory guidance during project team meeting to other groups within RA, Technical Operations, Quality, and Commercial Operations.
- Coordinate, manage and lead all assigned projects including management of budget, timelines, submission planning.
- Life Cycle management for licensed products, in the US, Europe and other major regions.
- A scientific background (Pharmacy, Pharmacology, Chemistry, Biology, Medicine, etc
- 5 years’ experience within Regulatory
- Knowledge of English language are strictly required for cover the role.
- Experience with marketed products and products in early stages of development together to vaccines or biologics background is highly desirable.
To discuss this position in more detail please contact Reesa Berry on +44 1483 397070 or send an email to email@example.com