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