Regulatory / Regulatory Affairs CMC Director ** Berkshire, M4 Corridor ** Global role, EU & US

Reference: TM10499

Expiry Date: 14-12-2020

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Windsor and Maidenhead
United Kingdom

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Job Description

Regulatory / Regulatory Affairs CMC Director ** Berkshire, M4 Corridor ** Global role, EU & US

My highly innovative and hugely successful pharmaceutical client is expanding and developing its Global Regulatory Affairs CMC department from their Berkshire offices and are now seeking a Regulatory Affairs Director of CMC for a Global role.  You will provide strong results orientated leadership on regulatory strategy for a leading Brand with strong data and an exciting future.


The salary and packages available is excellent and will include a strong salary, car allowance, bonus, high level pension and healthcare bundles plus lucrative company share options.

Location: South-East, Berkshire, M4 Corridor, commutable from Maidenhead, Slough, High Wycombe, Uxbridge, Reading, Oxford and London.

Role / Description:

Reporting directly into the Global Head of CMC, you will be the Regulatory CMC lead for a new  MAA/NDA project and/or a  major Lifecycle initiative project for a high value (Global) Brand.

This unique position will also grow to cover all phases of the drug development process from being involved with cross-functional teams from proof of concept/Phase 1 to providing regulatory input into the preparation of CTA/IND’s for clinical submissions to preparing MAA/NDA’s for initial filing through to post approval leadership and global optimisation programmes.

You will need to be a highly motivated Regulatory affairs CMC professional with experience of working through different phases of the drug development process, operating  as the CMC lead for a number of projects in both pre and post approval stage.

To Apply!

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

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