Regulatory Affairs CMC Associate Director - Berkshire, UK

Reference: Oli10502

Expiry Date: 20-08-2020

Category Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Maidenhead
Windsor and Maidenhead
United Kingdom

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Job Description

Regulatory Affairs CMC Associate Director - Berkshire, UK - flexible working hours and strong package

Location: M4 Corridor, Berkshire

We have an opportunity for a Regulatory Affairs CMC Associate Director with our global pharmaceutical client. Our client has an expansive pipeline that has steadily grown in recent years and they now have several promising drug candidates and are planning several major submissions in the next 5 years. This role will suit a Regulatory Affairs professional who likes variety and technical challenges, but who also thrives in a leadership role that has lots of autonomy.

As a Regulatory Affairs CMC Associate Director you will be involved in leading various projects at various stages of the lifecycle. The role will be very hands-on, initially leading projects in Phase I & II, authoring first drafts of IMPDs, doing the groundwork in development as well as co-authoring and leading all agency interactions and Scientific Advice. In the medium and longer term you will also be able to see these projects through to PIII and support the MAA or major Line Extensions and/or Variations.

This is a great opportunity to take the lead for interesting and challenging projects where you will have good levels of autonomy on strategy development, leading cross functional meetings and Health Authority interaction /negotiations. This role will appeal to a well-rounded Regulatory Affairs CMC professional who is willing to roll up their sleeves and enjoy the technical challenge of producing/developing strong  IMPD's.

Our client offers a great package including competitive salary, strong bonus, car allowance, medical and life insurance. There is real flexibility around start and finish times of the working day so you can avoid rush-hour commuting. There are options available to work from home 2 days a week (after induction and probation periods).

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Oli or Theo on +44 (0)207 801 3388 or +44 (0)207 801 3384 . All applications are received in confidence! ADV Talent Partners will help you each and every step of the way through the hiring process!

Note: My client has committed to do digital hiring using Skype (VC), and has a new digital on-boarding and induction training process in place to allow a smooth transition during MERS-COV-2 outbreak. During the next period, new hires will be allowed to work from home full-time, until such a time occurs when normal working returns.

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