We are looking for Regulatory Affairs Specialist - Export for pharmaceutical company based in Devon.
Purpose of this role is to deal with international submissions in line with the commercial export strategy & in liaison with the Commercial Team and review existing older MA's, held by the company since the 1990's, in order to reformat to allow successful submissions into new territories.
Challenging part of this role:
- Successful delivery of licensing strategies with successful product registrations.
- Relevant contribution to the licensing planning process.
- Company compliance with regulatory legislation.
- Degree educated - life sciences degree
- Experience of working within the Pharmaceutical Regulatory Industry (Regulatory Consultancy, Regulatory Agency or Pharma Company). Must include licensing overseas (e.g. Middle East, Africa, Asia)
- Experience of licence application submissions via the decentralised and centralised routes within Europe and submissions outside of the EU to global regulatory agencies
- Working with overseas regulators to co-ordinate the submission processes for export strategies
- Specialist licensing experience within the Pharmaceutical industry
- Understanding & experience of Good Manufacturing Practice/Good Distribution Practice
If you are interested in this amazing opportunity, please apply by sending your up to date CV or call 01753 589 637.
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.