For my customer in Munich (Biotech Start-Up), I am looking for a regulatory affairs manager.
As the company is still in early-stage development, you will need to act as centre of expertise for the company as a whole. This includes staying up-to-date on EU and FDA guidelines and ensuring that colleagues are aware of the implications.
In this position you will have the following responsibilities:
- Create regulatory documents (IMPD, IND, CTD Module 3)
- Communicate with internal and external partners in the area of regulatory affairs
- Work very closely with health authorities, partner companies and other internal departments to ensure a successful cooperation
- Answer queries from health authorities
- Provide regulatory expertise for clinical trials
- Develop regulatory strategies
Required experience and qualifications for this position:
- Master or PhD in a related field (Chemistry, Biology, Pharmacy)
- At least 3 years' experience in the area of regulatory affairs (preferably in a Biotech company)
- International experience
- Fluent English and German
The next step:
If you are interested in this position and would like to find out more, then please contact me.
Andrew Pride - Regulatory Affairs
Principal Recruitment Consultant
T: +49 (0) 89 - 5519 7767
Progressive München - Pharma
Sthree Germany is acting as an Employment Agency in relation to this vacancy.