Manager Global Regulatory Affairs
An exciting opportunity to join a well-known regulatory consultancy in Europe that boasts the opportunity to support several regulatory activities for Pharmaceutical and Biotech Clients globally
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
- Interact with Regulatory Agencies on behalf of clients
- Manage the MAA procedure on behalf of clients
Key Requirements :
- Masters or PhD. in life sciences
- At least 6-8 years Project Management and Regulatory Affairs experience
- Understanding of FDA and ICH regulations and guidelines
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