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
Progressive München - Pharma
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