Profile:
Regulatory Consultant
£40,000 - £50,000 dependent on background and experience.
Plus benefits
Cambridge
Our client is an expanding expert in Clinical and Regulatory Consultancy providing practical advice and support to the pharmaceutical industry to move products from early concept and into the clinic.
They are looking for a Regulatory Consultant to join their specialist team.
You will be responsible for preparing regulatory sections of clinical trial and marketing authorisation applications for both Europe and the USA, reviewing CMC plans, advising on regulatory requirements, interacting with Regulatory agencies and with clients and working as part of project development teams.
Tasks will include reviewing CMC plans against EU/USA guidelines. To advise on regulatory requirements for Clinical Trial and Marketing Applications. Writing regulatory documents including Module 3 of the CTD.
Your CV will demonstrate a good background (3-4 years) in CMC aspects of biotechnology products and is already working in regulatory affairs. Candidates with biotechnology CMC background and who would like to move into regulatory affairs can be considered.
Existing experience with advanced therapies (gene therapy, somatic cell therapies, tissue engineered products) would be of great advantage.
Previous interactions with regulatory authorities in the EU or USA would be desirable.
The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the country where the job is based. Carlisle Staffing plc, trading as SRG is an Employment Business/Agency.
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Clinical Temp User 1 |
