Stellenausschreibung


Manager Regulatory Affairs


Our Profile

ABX is a young, fast-growing and dynamic chemical and pharmaceutical company based in Radeberg near Dresden, Germany. We are the world leader in the production of precursors and kits for molecular imaging and therapy. These are mainly used in modern personalized medicine for the diagnosis and therapy of oncological and neurological diseases.

We are looking for a highly motivated Manager Regulatory Affairs as soon as possible.


Key Tasks and Responsibilities

  • Timely management and preparation of high-quality regulatory documents and submissions for clinical trials and marketing authorisation applications
  • Regulatory life-cycle management for our products
  • Monitoring of compliance with applicable regulatory requirements
  • Communication with international regulatory authorities
  • Collaboration with our customers
  • Project management


Your Qualification

  • Experience and knowledge in regulatory affairs management
  • Degree in natural sciences (e.g. chemistry, biochemistry, pharmacy)
  • Knowledge of GMP and change management in the regulatory environment
  • Experience in project management
  • Very good computer skills (Word, Excel, Powerpoint)
  • Very good written and spoken German and English skills
  • Excellent communication skills, especially in collaboration with our customers and authorities
  • Reliability, flexibility, sense of responsibility and accuracy


We offer you

  • an interesting and varied job in an open-minded team
  • a modern working environment in the pharmaceutical industry and internationally operating company
  • good general conditions and a familiar working atmosphere
  • job ticket / travel allowance
  • flexible working hours

 

Worktime: 40 hours per week
Starting date: immediately
Place of work:  01454 Radeberg (near Dresden)

 

If you are interested in shaping your future in our company, we look forward to receiving your detailed application including information on your salary expectations and earliest possible starting date by email.


Contact

Please send your informative application to:

ABX advanced biochemical compounds –
Biomedizinische Forschungsreagenzien GmbH
Ute Egerland
Heinrich-Gläser-Strasse 10-14
01454 Radeberg

phone:  (0 35 28) 40 41 60
email: bewerbungen@abx.de

 


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