Regulatory Affairs Consultant
REGAFFSCON_1694106568
Posted: 07/09/2023
- £400 - £450 PER DAY
- Uxbridge, London
- Contract
Regulatory Consultant
12 month contract
37.5 hours per week
Hybrid - 2/3 days per week - Uxbridge or Cambridge
£450 per day - inside IR35
Global biopharmaceutical company - virology team
Essential Duties and Job Functions
- Responsible for advising on regulatory strategies and preparing submissions for designated products
- Support post-marketing activities for the preparation of regulatory submissions via the EU centralised procedure, which may include, variations, PSURs/RMPs, responses to questions and renewals.
- Support post-marketing activities for the preparation of regulatory submissions in given markets outside of the EU, which may include, but is not restricted to variations, PSURs/RMPs, responses to questions and renewals.
- Prepare and maintain labelling to support MAAs and other post-licensing activities.
- Support new and ongoing clinical trials.
Education and/or Experience required
- Life sciences degree
- 3-5+ years of experience in pharmaceutical Regulatory Affairs
- Experience with EU centralised procedure
- Experience in supporting post-licensing management of variations, renewals, responses to questions, Follow-up Measures, PSURs etc for Centralized products.
- Experience supporting clinical trial applications
Guy Shipman
Recruitment Team Lead
