Expiry Date: 18-09-2020
Category Regulatory Affairs
Salary: On Application
Job Type: Full Time
Global Regulatory Affairs CMC Team Leader for Biologicals, EU & US - Berkshire UK
This is an opportunity for an experienced Regulatory CMC professional to join a successful Biotechnology company as a CMC Global Team Leader, managing strategic development projects for mAbs, in both the EU and the US markets.
The location is easily commutable from Slough, Maidenhead, Windsor, Reading, Uxbridge, High Wycombe and also, Central and West London. Car parking is available and our client offers a great package including competitive salary, strong bonus, car allowance, medical for you and your family, plus a lucrative stock options scheme and full insurances.
This is a medium sized biopharmaceutical company with its heritage and roots in Europe so it’s not a US centric company, decisions are made from its Global HQ in the UK. The leadership here has created an environment where people feel empowered, motivated to learn and develop and where promotions are based on merit, which allows people to develop and reach their full potential.
My client has several successful global products on the market and have a busy pipeline of new chemical and biological entities in development. So you will have the choice of good indications and working on less projects, but with more input, depth leadership. You will also be managing a team of 4 experienced Regulatory CMC managers, with the team set to continue to grow.
You will use your regulatory affairs experience to successfully define, plan and implement the regulatory strategy for assigned regulatory CMC submissions. You will provide regulatory CMC leadership to cross functional teams and lead responses to the EMA and FDA (via your EU & US liaisons who will report directly to you). So this will be a good mix of strategic leadership, people management and also remaining technically hands-on with some of your projects!
Interested candidates should have at least 10 years in regulatory CMC (biologicals ideally) across the full life cycle. You will be accountable for leading the authoring and approval of regulatory CMC sections of (IMPDs, MAAs, BLAs, NDAs, PiPs,) for large molecules, so experience of authoring Module 3 is essential.
In return, you will receive a very competitive package with yearly bonus and lucrative stock options, plus real career development with people management opportunities in a global role, from the global HQ based in the UK.
To apply for this role, please press the red “Apply for position” button, or contact Theo Moore or Oli Dimitrov on +44 (0)207 801 3384 or on +44 (0)207 801 3388. 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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