Senior Regulatory Affairs Manager

Job Ref: J25820
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 09 March 2018
  • Paris, Île-de-France, France
  • €105,000 per Annum
  • Neal Panting
  • 01753 589601

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The client is currently pursuing multiple phase III studies in human medicine on a Global basis.

Responsibilities include:

  • Mange all aspects related to the preparation, tracking, compilation, publishing and technical quality control of regulatory submissions
  • Manage the preparation, documentation and submission of marketing authorisation applications
  • Participate in the drafting of registration dossiers (eCTD modules 1 and 2)
  • Prepare regulatory responses to health authorities
  • Interface with the national and international health authorities
  • Provide regulatory guidance to departments and clinical project teams


  • Post-graduate science degree (Pharm.D, or Ph.D.) Qualified
  • Extensive experience in Regulatory affairs including experience in team and project management
  • Significant experience in bidding and drafting regulatory responses to local health authorities in launching studies in a country
  • Significant experience (in a pharmaceutical company) in drafting regulatory responses and clinical study documents (protocol, investigator brochure, clinical report)
  • Fluent English and French

If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589626

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.