Regulatory Affairs Manager - ATMP mfd 25-40h
Regulatory Affairs Manager - ATMP mfd 25-40h
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Salary Not Disclosed
1 Vacancy
Job Description
In your role as a Regulatory Affairs Manager you will be involved in the development of ATMPs.
- You will support the Regulatory Affairs department in preparing and reviewing approval documents for our products in cell and gene therapy.
- You will compile dossiers and take care of the submission of applications to the relevant national and international authorities with a focus on clinical trials. In this context you will also interact with clients and support them with their applications.
- You identify and communicate regulatory requirements and provide regulatory advice on the development and maintenance of products to the team (e.g. R&D Manufacturing Quality Control Marketing & Sales). Furthermore you review documents from a regulatory perspective.
- You support the team in providing regulatory assessment of changes such as manufacturing process changes (change control).
- This includes the determination of the impact of the change on regulatory filings and the preparation of appropriate documents.
Qualifications :
- You have a PhD in biology pharmacy biochemistry or a similar speciality.
- Several years of experience in the field of Drug Regulatory Affairs is essential. Experience with biological products is welcome.
- Your passion for organisation and regulation is combined with a solid knowledge of the relevant laws and guidelines.
- Basic knowledge of GMP is desirable.
- You enjoy working independently and have strong communication skills in English both written and spoken.
Additional Information :
This position is to be filled with a weekly working time between 25 40h.
What we offer
- A modern workplace in Bergisch Gladbach with flexible working hours enabling time management on your own terms and an opportunity for some limited mobile working
- Exciting opportunities in contributing to the development of future personalized and advanced therapies
- A collegial corporate culture based on intercultural cooperation and short communication channels
- Personalized employee development program with specialist and personal training courses provided by our own Miltenyi University
- Diverse corporate benefits regarding employee health sport and staff event
You and your talent are welcome here in our inclusive and collaborative environment. So come as you are. Regardless of gender sexual identity age ethnicity religion or disability.
We look forward to your application
If you would like to work in an open creative and helpful team we offer you the right environment here. We look forward to receiving your application with your salary expectations and availability.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
