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

Reference: TM10499

Expiry Date: 14-08-2020

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Maidenhead
Windsor and Maidenhead
United Kingdom

Apply for position

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.

Benefits:

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.

We provide a high level of service because we believe this matters. Our people place individuals at the Specialist, Expert, Regional and Global Head levels, so if you want some advice on when or how to make your next step, or to understand what that next step might look like, let’s collaborate and explore these ideas with each other. ADV Talent Partners only advertise around 30% of our active roles, so for us to really help you, please Register or call us. We provide permanent and contract roles in the following areas, across the USA, Europe and Asia Pacific. General switchboard number +44 (0)207 801 3380.

GDPR & Data Protection: Your information is safeguarded for GDPR, and you will have the right to edit, amend or delete and ’’be forgotten’’ at any time after your initial registration.