Senior Regulatory Affairs Manager - Clinical Trials
Job Title: | Senior Regulatory Affairs Manager - Clinical Trials |
Contract Type: | Permanent |
Location: | Frankfurt am Main, Hessen |
Industry: | |
Salary: | Negotiable |
Start Date: | ASAP |
Reference: | DP 123334_1505831055 |
Contact Name: | Daniel Perkins |
Contact Email: | d.perkins@sciproglobal.de |
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 d.perkins@sciproglobal.de directly.
Good luck!!

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