UK Regulatory Affairs Affiliate
Our client, a specialist pharmaceutical company who provide generic medicines, commercial brands and specialist supply products to various sectors, require a Regulatory Affairs professional to oversee the companies regulatory activity and compliance within the UK.
- Representing the company at all times on all regulatory affairs matters
- Handling of all regulatory matters including but not limited to variations, and renewals of marketing authorisations
- Follow up registration applications (DCP's, MRP's and National MAAs) with the UK regulatory authorities
- Prepare and submit the necessary documentation to the regulatory authorities
- BSc. or MSc. in Pharmacy, Chemistry or related Science.
- 1+ year experience in generic pharmaceutical industry (Regulatory affairs or artwork function)
- Experience in local Regulatory Affairs/Registration, preferably in generics
- Good knowledge of post-marketing authorisation including variations (Type IA/Type IB/Type II and PIQ notification/full applications) and renewals.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.In case you have difficulty in applying or if you have any questions, please call Nicholas Walker on 0207 4400 678 or upload your CV on our website www.proclinical.jobs . Full job description available on request.ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.