Senior Regulaotry Manager - CMC Biotech - Berkshire

Highly Competitive Salary
Sep 22, 2016
Oct 20, 2016
David Nixon
Result Type
Position Type
Full Time

Senior Regulatory Manager - CMC Biotech, Berkshire - a unique opportunity has arisen to join a leading biopharmaceutical organisation focused on improving the lives of patients with serious diseases. This organisation, famed for their development of staff and work life balance, are looking to recruit a senior manager or manager level individual into their CMC team. Reporting to the Associate Director you will have hands on and strategic oversight and work closely with SMEs and technical teams to develop submission packages which achieve favorable approvals.

The primary activities will be authoring and submission of module III sections exclusively for biotech products. As a minimum requirement you must have experience in biologics from a CMC perspective. In addition you will have extensive agency meeting experience ideally with the EMA and have centralised procedure experience. The products are both for adult and paediatric use and there would be a number of new indications and line extensions

This is likely to be a popular role and offers a once in a career opportunity to work on truly ground breaking products which improve live beyond compare. Please get in touch on the number below for a confidential discussion.


To Apply:

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 David Nixon on +44(0)203 0789 544 or upload your CV on our website . 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.