Expiry Date: 14-12-2020
Category Regulatory Affairs
Job Type: Full Time
Windsor and Maidenhead
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 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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