Expiry Date: 02-10-2020
Category Regulatory Affairs
Job Type: Full Time
Regulatory Affairs CMC Senior Manager, Biologicals - Early Dev. Clinical Lead - Global Role, Berkshire
We have a great new role with a dynamic and expansive Global biotechnology company offering a great opportunity for a Regulatory Affairs CMC Senior Manager to work in a broad based role across a number of really interesting biological products.
Why is this a good role?
There are many programs in development including mAbs, breakthrough drugs, Cell and Gene therapy products….which makes it an exciting time to join! It’s also a Global role so you will have input on EU and US strategy and also have a great opportunity to progress to Associate Director grade.
About My Client
Few biotechnology companies have seen such a steady rise in terms of their turnover or high value assets as my client, whom have double in size every 4 years in the last 15. Sales are well over 15Billion a year and steadily increasing year on year and they have over 25 indications currently running in development.
This organization has developed successful therapeutics in all of the modalities, small and large molecules, oligos, viral vectors, they continue to be at the forefront in terms of registrations of the newer sciences, and have a pipeline which is very novel, they are not unwilling to go after some of the most stubborn disease areas.
Your Background & The Role
This is an early stage development role, so some experience of working on early stage products is needed, but candidates with P3 experience will also be considered. A flexible approach is needed and there is also the chance that you could also lead or support a MAA/BLA in the future as my client likes to help its RA CMC team members to expand and develop their knowledge and expertise.
Soft skills needed include good coordination, good communication skills, the ability to make deadlines and to be a team player. Experience of negotiating and answers questions form HA’s is needed and any Scientific Advice meeting experience would be welcome.
Package & Benefits
You will be offered a strong basic salary with a high level bonus, car allowance and lucrative share package, to make this arguably the strongest package available at Snr manager grade in the UK.
To apply for this role, please press the red “Apply for position” button, or contact Theo Moore on +44 (0)207 801 3384 or my colleague Oli Dimitrov on +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!
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