Clinical affairs manager Jobs in Leichlingen

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 :

Additional Information :

What we offer

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 : Employment Type :

Fulltime

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Department / Functional Area : Regulatory Affairs

Vacancy : 1