Regulatory Affairs CMC Associate Director - Berkshire, UK, flexible working hours and strong package
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, please send a full CV to CV@AdvTalent.com, or alternatively contact Theo or Oli on +44 (0)207 801 3384 or +44 (0)207 801 3388. We are assigned these roles by our client and will provide you with support throughout the hiring process.
About Advanced Search & Our Network
Advanced Search, has a network of affiliated companies including ADV Regulatory, and ADV Talent Partners. Together, we are specialists in Regulatory Affairs and Life Sciences recruitment especially around mAbs and biologicals for roles in R&D and Commercialization and have been established and hiring in this area since 2005.
Our Regulatory Affairs team know their subject matter areas and our mission is to help you grow your career each and every step of the way. We have helped many of today's leading companies develop strong regulatory sciences functions and are known for hiring complimentary teams that work well with each other, at owner-contributor, strategy leading and people management levels.
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+44 (0)207 801 3380
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