Regulatory Affairs Manager - ATMP (m|f|d)

• 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.
• 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.

• 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.

We encourage a creative working environment driven by pioneering spirit – to seek new horizons – boldly envisioning the future and turning it into reality. Today, more than 4,700 experts from over 50 countries contribute to our sustainable success.