Regulatory Manager - CMC Manufacturing - Hannover
A manufacturing site in Germany was just acquired by a world-renowned group of companies who are committed to improving it and expanding their already very successful group of professionals. As part of their expansion they are looking to take on a new Regulatory Affairs CMC manager with experience in sterile manufacturing. The position will allow you to perform in a global capacity and deal with many different regulatory agencies, including the FDA, MHRA, BfArM, etc. This will greatly improve your liaison exp., opening you up to new opportunities in the future.
- Compile and check pharmaceutical quality documentation for national and international regulatory Markets
- Respond to deficiency letters from authorities
- Supervise development projects and marketing authorization procedures in quality documentation
- Work together with key clients, taking on new requests in regulatory and advising on how to proceed
- Lifescience degree
- Experience with Pharmaceutical Quality Module 3 Documentation
- Experience in dealing with official regulatory bodies (several countries accepted!)
- Fluency in English, spoken and written
For more information please contact Sebastian Pal at +49 (0) 892 109 3363. To request a call back e-mail your number and availability to firstname.lastname@example.org. I look forward to receiving your application.
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