EPM are currently working with a Biopharmaceutical company, who are based in the German region of Switzerland. They are looking for a Director Of Regulatory Affairs for a 12 month contract with possibility of extension.
This company is leading the way in ground breaking T-cell therapy products transforming the lives of patients with serious diseases. You will have the opportunity to shape their RA strategy across Europe and have a real impact on developing products.
Responsibilities:
- Collaborating with Clinical, Regulatory, Operations as well as external vendors to implement submission strategy.
- Monitor regulatory intelligence to give advice to product development project teams with respect to the EU regulatory requirements and trends that affect cooperate strategy.
- Supporting preparation, editing and review of submissions including regulatory agency meeting requests, briefing documents, CTA amendments, MAA's (and respective variations) and labelling preparation.
- Manage all post-approval regulatory obligations for the EU market
- Set up and manage the process in Europe for the regulatory promotional compliance.
Key Experience Required:
- 15 years in Global Regulatory Affairs positions, with 10 of these years spent in EU RA with an emphasis on biological products.
- Good understanding of pharmaceutical biologics drug development, CMC regulatory experience and knowledge of cellular therapies.
- Extensive European Markets RA knowledge
- Has experience leading the regulatory submission and approval process of NCE's/NBE.
- Leadership skills, preferably of a international team
- Fluent in English