NEW 1 year Contract – Regulatory CMC Manager / Snr Manager Consultant – NCEs, Berkshire, M4 Corridor, UK

Reference: Oli16012021

Expiry Date: 15-12-2021

Category Regulatory Affairs

Salary: Negotiable

Job Type: Contractor

Location:
Windsor
Windsor and Maidenhead
United Kingdom

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Job Description

This is a 1 year Regulatory CMC Contract opportunity with an R&D driven pharmaceutical company with several new products coming in Phase 2 and Phase 3, as well as a busy early development pipeline.

In this role you will be working on a variety of projects based on your strengths and experience, but you will have the opportunity to gain more IMPD/IND authoring for products in late stage development in the EU and the US as well as Module 3 build for an initial Marketing Authorisation Applications. This company has planned several major submissions in the next few years. 

You will provide regional strategic and operational Regulatory Affairs CMC expertise. Write and review global and regional Regulatory CMC submission documents, IMPDs, INDs, new MAAs and NDAs etc. As well as manage CMC aspects of Health Authority questions and negotiations.

Location: M4 Corridor of Berkshire. Easily commutable by car or public transport when offices open post Covid-19. Onboarding digitally and working from home in the months to come. Flexibility to work from home 2 days per week (post Covid).

The length of the contract is 12 months with possible extension.

Interested in the above? Please, apply or get in touch for more information.

To apply for this role, please press the red “Apply for position” button, or contact me Oli Dimitrov on +44 (0)207 801 3388 or Theo Moore on +44 (0)207 801 3384 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

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