Regulatory Affairs Project Manager
Calling all Senior Regulatory Affairs Project Managers, this is a unique opportunity to make real change within the regulatory affairs field.
I'm working with a client in Bavaria Germany who is a leading consultancy firm within the Regulatory Field. You will be closely working with a wider team to make real change within organisations across the globe within the Pharmaceutical and Medical Device Field.
All while representing company standards like innovation, quality and excellence.
Responsibilities :
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.
- 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.
Requirements :
- Master or PhD. in life sciences, medicine or veterinary medicine.
- At least 7 years Project Management and Regulatory Affairs experience.
- Good understanding in 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.
Regulatory Affairs Project Manager
Calling all Senior Regulatory Affairs Project Managers, this is a unique opportunity to make real change within the regulatory affairs field. At least 7 years Project Management and Regulatory Affairs experience. This position covers project management of regulatory activities from early development...
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