Expiry Date: 28-02-2021
Category Regulatory Affairs
Salary: On Application
Job Type: Full Time
Windsor and Maidenhead
Regulatory Affairs Associate Director of CMC (Biologicals)
Cover early & late phase development projects
This role is good mix of strategic input, global project management and covers early & late phase development and global registration activities. Promotion prospects are very strong and there are options available to become a technical CMC specialist or move into people/team leadership.
Location: Maidenhead, Berkshire, South-East.
Adv Talent Partners have a new Regulatory Affairs CMC role based at the Head Office of one of the world’s most dynamic and successful Biotechnology Company.
The salary and package is exceptional for this role, including a strong basic salary + bonus + shares options + full healthcare and medical + strong pension + high level re-location package included. There is also a great onsite restaurant, flexible working hours, extensive parking available, good transport links and many company clubs & events to ensure a great work-life balance!
Role / Description: You will be the regional lead providing regulatory affairs CMC insight and intelligence on the regions to foster best approaches, from developing regional CMC RA strategies through to the preparation and submission of CMC documentation for development and registration for all major Global regions (EU and US).
You will need to be strong in leading regional CMC strategies through to fulfilment, optimising timelines where possible by working well with cross functional departments and your colleagues in Global (Therapy) Regulatory.
There are many reason to join this amazing organisation including a dynamic, creative & energising culture, an expansive and strong pipeline, multiple opportunities for personal development and the freedom and flexibility to have a strong strategic input into your projects.
You will need at least 10 years of Regulatory Affairs CMC experience and be ready for a role where you have real autonomy, scope and responsibility for a varied Biological product portfolio as the Global Strategic Leader.
To apply for this role, please press the red “Apply for position” button, or contact Theo or Oli on +44 (0)207 801 3384 or +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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