Regulatory CMC Director *** mAbs and Team Mngt role ** Have strong EU strategy – gain global for both NBEs and Marketed? M4 Corridor
Regulatory CMC Director *** Pure mAbs and Team Management role ** Have strong EU strategy – gain global for both NBEs and Marketed?
This role can be based in the West of London area, within an easy commute of West London, Surry, Bucks, Berks and Middlesex and Herts.
My role has pretty much an ideal ticket, its global, it has both NBEs in development AND marketed, a team of direct reports in a company where regulatory is seen as a value driver and business enabler, and CMC bio regulatory is a global team not a regional one. This role is to lead this team, reporting to a VP of CMC RA who is a permissive democrat as a manager and has a great reputation for advocating for / defending and developing her people:-
- Want to lead a team which has a broad remit, which is not working purely on marketed products CMC Bio variations, but on NMEs including 4 mAbs in Ph 2B/3?
- What to ‘lead the strategy CMC leaders’ for development and shaping of global biologicals regulatory strategies? To bring IMPs through the phases through your team?
- Do you have the skills to help the crossfunctional teams and help technical operations bring new mAbs into commercial manufacture and then develop with your direct reports and in global matrix, new solutions including their existing injector platform to more advanced companions?
- Do you want to have a team of more than 10 FTEs, based worldwide, and help them ladder their skills and develop into future leaders in their own right?
You will have a strong track record in regulatory CMC for biologicals and want to combine this with a leadership role, however, although we would like you to have US and EU experience, we will be ready to accept applications if you only have direct experience of the EU only or the US only, and want to gain stronger global expertise. In return we are seeking someone who has managed teams of at least 5 FTEs and now wants to manage the bigger teams.
Personality wide, you will be someone who is seen as working well with people, able to zip up / down and across the global matrix, to connect people and ideas, and want to drive technology platforms across brands, by supporting the commercial teams at the higher levels to shape and polish lifecycle strategies, where lifecycle development planning starts in Ph 3 and includes the new frontiers technology sets, from PFS to Injectors and Companions, your team is instrumental in making these objectives happen.
We are instructed to find the right applicant in May 2018 and have a closing date of the 20th.
To apply for this role, please contact me, Matt Greig, on +447918679405 or send an email to me, in private to email@example.com
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