Senior Regulatory Affairs Manager
A popular hospital in search of an experienced Regulatory Affairs Manager to ensure regulatory excellence in Switzerland.
- Project management of LOQ responses
- Timelines management
- Key Subject Matter Expert (SME) follow-up and tracking
- Guideline research
- Management of Readability testing
- Regulatory Slide preparation
- Procedure overviews
- Status updates
Skills and Experience:
- Graduate in a life science subject as a minimum, post graduate degree desirable
- Minimum 5+ years' proven experience in an appropriate regulatory role, with experience in Advanced Therapy Medicinal Products preferred
- Experience in implementing and helping to develop regulatory strategies for Advanced Therapy Medicinal Products including orphan indications
- Keeps up to date with professional knowledge, expertise and best practice.
- Excellent oral and written communication skills.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.