Senior Associate Regulatory Affairs

Regulatory Professionals
13 Nov 2017
15 Nov 2017
Contract Type
Full Time
Senior Associate Regulatory Affairs
12 month contract
Cambridge based
Attractive Daily Rate
This internationally recgonised healthcare specialist is seeking a Senior Associate Regulatory Affairs to join their established team on individuals on a 12 month contract basis, to be office based in Cambridge. As leaders in developing pioneering medicines to fight serious illness, you will be working with the Regional Regulatory Lead in creation and submission of regulatory documents.

Responsibilities Includes;
- Supporting regional pre filling activies including CTA/ IMPD development and submission
- Pre MAA filing
- Provide and maintain CTA/MAA documentation support
- Provide primary authorship to routine regulatory correspondence
- Preparation and submission of CMC for worldwide submissions

Candidate Requirements
- Life sciences degree or equivalent
- 2-4 years years Regulatory experience
- Experience in liaising with government authorities and trade organisations within Regulatory Affairs
- Strong oral and written organisation skills and an understanding of the drug development process

Job reference: J31249

regulatory, senior associate regulatory affairs, regulatory officer, regulatory manager, CMC submissions, CTA, MAA, pre approval, post approval, life sciences, IMPD, Cambridge, Cambridgeshire, Herts, Hertfordshire, Bedfordshire, London, North London, Middlesex