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Regulatory Project Manager
- Posted 28 March 2023
- LocationMunich
- Job type Permanent
- Reference83342
- Contact NameDavid Skinner
Job description
Regulatory Project Manager
Munich, Germany
This position covers project management of regulatory activities from early development, i.e. pre-clinical scientific advice to Project Management of dossier preparation for MAA or BLA/NDA filing.
Tasks & Responsibilities:
Manage EU and FDA Marketing Authorisation Application procedures including:
Munich, Germany
This position covers project management of regulatory activities from early development, i.e. pre-clinical scientific advice to Project Management of dossier preparation for MAA or BLA/NDA filing.
Tasks & Responsibilities:
Manage EU and FDA Marketing Authorisation Application procedures including:
-
- preparation of Module 1 documents
- assignment and management of team resources
- co-ordination of Mod 2 & 3
- tracking Modules 4 & 5
- preparation and track project plans
- interaction with Regulatory Agencies on behalf of clients before, during and after approval
- management the MAA procedure on behalf of clients
- Provide regulatory advice to clients
- Prepare and manage project plans
- Request Scientific Advice meetings on behalf of clients including preparation of supportive documentation
- Master or PhD. in life sciences, medicine or veterinary medicine
- At least 10 years Project Management and Regulatory Affairs experience, understanding of FDA and ICH regulations and guidelines
- Competent with Project Management tools and software
- Excellent communication skills, strategic thinker, solution orientated
- Ability to work independently and manage multiple tasks simultaneously under time constraints. Flexible with excellent prioritisation skills