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Senior Regulatory Affairs CMC Manager Biologics (m/f/x)

  • Location: Schwandorf in Bayern
  • Salary: €50000 - €70000 per annum + package negotiable per year
  • Job Type:Permanent

Posted etwa 12 Stunden her

  • Sector: Pharmabranche
  • Contact: Marlene Inderhees
  • Contact Email:
  • Expiry Date: 25 June 2023
  • Job Ref: 54_2023_1685092599

Senior Regulatory Affairs CMC Manager Biologics (m/f/x) | Munich | Pharma

What will your tasks as Senior Manager Regulatory Affairs CMC Biologics involve?

  • Development of regulatory strategies incl. risk assessments and change control processes
  • Preparation of CMC documentation (IMPDs, Module 2.3 & 3) and subsequent review
  • Ensuring regulatory compliance (EU focus)
  • Close cooperation with CMC Regulatory Affairs and technical experts across the group
  • Represent RA CMC in global and local project team meetings
  • Make essential contributions to drug development, manufacturing and commercialisation through advanced EU regulatory expertise

What does this position offer?

  • Contract type: Temporary employee - limited to 18 months
  • Holiday: 30 days / year
  • Working hours: 40 hours / week
  • Accessibility: On-site parking and very good public transport connections
  • Start date: As soon as possible

The position offers you the opportunity of excellent training with very exciting projects in the field of ADCs, Oncology Indication; Phase3/MAA, global filing and global collaboration.

What qualifications should you bring with you?

  • Completed scientific/pharmaceutical studies
  • 1-2 years of experience in CMC would be an advantage (not a must!)
  • Very good communication skills in dealing with interdisciplinary multicultural teams
  • Very good knowledge of German & English
  • Good knowledge in data processing

Information about our client:

The company is one of the 20 largest pharmaceutical companies in the world and operates in 12 European countries. With over 15,000 employees in 20 countries, the company develops and markets innovative medicines for patients in the field of hypertension, thrombotic diseases and in the field of oncology. Does this position appeal to you? Then you should apply right away! If you would like to receive further or alternative positions, I would also be pleased to receive your application!

Application process:

  • Curriculum vitae to my
  • Telephone call with introduction of the company
  • I am your contact person for the entire application process (interviews to contract negotiations), i.e. you do not have to apply yourself.
  • Discussion of other exclusive positions tailored to your profile

My contact details:

I am looking forward to your application!