Senior Regulatory Affairs Manager - Clinical Trials

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!!