Expiry Date: 12-12-2019
Category Regulatory Affairs
Salary: On Application
Job Type: Full Time
Regulatory Affairs CMC Associate Director - London, UK
Regulatory Affairs CMC Associate Director role based in Central London - flexible working hours and strong package.
Location: London, Central London
We have an opportunity for a Regulatory Affairs CMC Associate Director with our global pharmaceutical client based in London. Our client has an expansive pipeline that has steadily grown in recent years and they develop medicines in over 8 different therapy areas and across a number of different formulations. The London HQ has recently overseen 4 product approvals, and there is still a high number of strong looking indications in development. 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.
Our client has the spirit of a start-up, but the backing of a global company. The benefit of this is a flat culture and a relaxed work environment where decisions are made easily and the Regulatory team sits on the same floor as most of the other R&D functions. This makes it’s easy to establish and main strong cross functional working relationships. Soft skills are important here – calm, cool and collective is the way to go, it’s not a rush-rush environment, more accurate and steady! The offices are based in a lovely part of Central London and is easily commutable via most of the major train stations (Kings Cross, Paddington, Waterloo, Liverpool Street and Victoria), with a number of tube stations less than a 10minute walk away.
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 ground work 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 a bonus, car allowance, share options, medical and life insurance for you and your family. The working week is 35 hours and 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 for this role, please press the red “Apply for position” button, or contact Oli Dimitrov on +44 (0)207 801 3388 or Theo Moore on +44 (0)207 801 3384 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.
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