Regulatory Project Manager
vor 4 Wochen
Regulatory Project Manager
Are you a results-oriented Regulatory Project Manager that loves to lead and execute regulatory projects with precision and efficiency. If so, this could be the role for you
The Regulatory Project Manager will play a pivotal role in ensuring that regulatory activities from early development through to dossier preparation for MMA and/or BLA/NDA filings.
Key Responsibilities:
Manage EU and FDA Marketing Authorisation Application procedures including:
- preparation of Module 1 documents
- co-ordination of Modules 2 & 3
- tracking Modules 4 & 5
- assignment and management of team resources
- 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, track and manage project plans
- Request Scientific Advice meetings on behalf of clients including preparation of supportive documentation
Key Requirements:
- Master or PhD. in life sciences, medicine or veterinary medicine
- At least 8-10 years Project Management and Regulatory Affairs experience
- Understanding of FDA and ICH regulations and guidelines
This role is based in Munich, Germany (Relocation from Europe supported) with a minimum of 3 days on site per week required (hybrid & flexible)
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