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Regulatory Affairs & Quality Manager, Frankfurt Region

Location: Hessen, Deutschland Salary: k.A.
Sector: Life Sciences Type: Permanent

For an important role at a leading biopharmaceutical company in Germany, I am currently looking for an experienced regulatory affairs and quality expert.

If you are looking for a new challenge in the Frankfurt region, then please read the job description below:

  • You have at least 3 years experience in the area of regulatory affairs/ quality and you would like to work for a global biopharmaceutical company?
  • You have a good understanding of the entire regulatory affairs processes and have worked in a matrix organisation?
  • You would like to work for a market leader with innovative products and a very international atmosphere?

In this position you will have the following responsibilities:

  • Support the global regulatory affairs teams with regulatory tasks for your assigned EU regions
  • Ensure labelling texts and packaging are compliant with regional regulations
  • Cooperation with business partners and service providers (including contract agreements)
  • Communicate with internal and external partners in the area of regulatory affairs and support regional/ local regulatory functions in their communication and relationships with health authorities
  • Management of Change Control processes
  • Develop, implement and maintain Quality Management Systems for the assigned regions
  • Provide support during inspections and audits, including any necessary follow-up
  • Ensure training of internal and external partners in accordance with GxP requirements

Required experience and qualifications for this position:

  • Master or PhD in a related field (Chemistry, Biology, Pharmacy)
  • At least 3 years' experience in the area of regulatory affairs
  • International experience
  • Fluent English and German (other languages are an advantage)

The next step:

If you are interested in this position and would like to find out more, then please contact me. I look forward to hearing from you!

Andrew Pride - Regulatory Affairs

Principal Recruitment Consultant

T: +49 (0) 89 - 5519 7767

a.pride(at)progressive.de

Progressive München - Pharma

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