Regulatory Affairs is a crucial process in advancing a product to market, in particular in the pharmaceutical industry! My client, a global pharmaceutical company, is requesting the addition of 2 new Regulatory Executives (submission specialists) to join their dynamic team in the CMC Regulatory Department. Candidates with BioPharmaceutical and Cellular Gene Therapy experience are desired to process an influx of new products awaiting approval and as such this is a very exciting and busy time to be joining the company.
Regulatory Executives Key Responsibilities:
- Dossier preparation and review in the Chemical, Manufacturing and Control (CMC) department.
- Organisation and preparation of paediatric investigation plans and any amendments that may follow.
- Managing the regulation of clinical trial applications within Europe and the US.
- Working together with other groups in the company to ensure that ongoing projects are captured in these documents and that any changes are recorded.
- Possess a BSc (minimum) degree, Biological Sciences, Biomedical Science etc - MSc candidates shall be favoured.
- Have 3+ years’ experience in pharmaceutical regulatory affairs.
- Ideally possess experience in both BioPharmaceuticals and Cellular Gene Therapy regulatory affairs.
- Have experience of both European and US markets with BioPharmaceuticals.
- Be highly organised, with excellent communication skills both verbal and written.
Please call Charles on 0161 942 7163 for more information on applying and the rates you can expect.