Senior Regulatory Affairs Manager - Clinical Trials

Senior Regulatory Affairs Manager - Clinical Trials

Job Title: Senior Regulatory Affairs Manager - Clinical Trials
Contract Type: Permanent
Location: Frankfurt am Main, Hessen
Salary: Negotiable
Start Date: ASAP
Reference: DP 123334_1505831055
Contact Name: Daniel Perkins
Contact Email:
Job Published: September 19, 2017 15:24

Job Description

Are you the next Senior Regulatory Affairs Manager with a focus on Clinical Trials?

Senior Regulatory Affairs Manager - Clinical Trials (m/f)

I am currently looking for a Regulatory Affairs professional with significant experience within the area of Clinical Trials to take on an absolutely fantastic opportunity for a leading pharmaceutical company based in the Hessen region.

The position:

  • Coordinating and overseeing approvals for CT's with pharmaceutical products and medical devices globally
  • Creation of dossiers and all neccessary documents for the submission of approval applications for CT's, with significant levels of guidance to team members
  • Overseeing the processes involved in the submissions to the appropriate Regulatory bodies and following through with them in association with team reps
  • Development of Regulatory Strategies for assigned projects
  • Creation and maintenance of CCDS
  • Regulatory advice, and consultations with authorities
  • Liasion point for all relevent authorities

Your experience:

  • Completed studies in pharmacy, biology or similar
  • Over 4 years experience in RA
  • Practical knowledge of how to manage approvals for clinical trials (CTA)
  • Solid knowledge of all stages of Drug Development
  • Thorough knowledge of up to date regulatory requirements
  • IMPD Knowledge
  • Very good knowledge of both German and English, written and spoken

If you are, or know a suitable candidate that is determined to take the next step in their career and really challenge themselves with a position of high repsonsibility, then please either respond to this advert, or alternatively send your application to directly.

Good luck!!

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