NEW **UK London Or Belgium or Switzerland** Sr Manager RA CMC Bio (mAbs) ** Authored VARs or IMPDs?

Location
West London or Belgium or Switzerland
Salary
On Application
Posted
15 Aug 2019
Closes
14 Sep 2019
Ref
MG10396 R9
Contact
Matt Greig
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

NEW ** W London Or Belgium or Switzerland ** Mngr / Sr Manager RA CMC Bio (mAbs) *** Have you authored VARs or IMPDs now want to work on BLAs? Partial Home-Working Available for the UK and Belgium Locations

My client is a well-known, global biopharmaceutical company with a pipeline which is multi-TA and mostly biologicals! This role is open to any Regulatory CMC Professional if you have now gained authoring experience on CMC dossiers for biologicals but want to do a "pure development" role, this organization is for you.

We ask you to consider the following:

  • Do you have CMC Variations experience for biologicals? Have you authored dossiers on CMC for biologicals for development or lifecycle subs and would like to now pivot to a pure development role?
  • Do you want to switch from a post-authorisation role to a pre-registration role?
  • Have you worked in an EU and International role and would now like to work in a Global team, in a Global role, focusing on submissions in the USA not just EU and major international markets?
  • Would you like, based on merit, evolve in to a Regulatory CMC strategist in the next 2-3 years?

They offer a merit-based advanced environment, as an example, and this role reports to one of our past placements who themselves have gained successive promotions over the last several years from their own diligence, and achievements. They offer a supportive environment, where you can prosper and learn from the team, who works in a global matrix and work from home 2 days a week (after the initial induction). 

If the answer to the above is YES, we would like to hear from you.

You will be joining in 2019 as a new team member jumping right into a NME in Ph2/3 development, with an expected filing to be prepared starting shortly after. You will help rollout the IMPDs, before moving to the BLA/MAA preparations, and will build on your authoring skills for M2.x and M3, to develop better knowledge of RA CMC strategy and in time the full MAA/BLA review process.

This is the type of experience which builds solid expertise and will help propel your career forward. Additionally, after the first round of IMPDs have been filed, you might be given the opportunity to work on a Ph. 1 NBE, so my hiring line manager is willing not just to say they will give you opportunities, but to actually do so!

      ___________________________________________________________________________

To apply for this role, please contact me, Theo Moore, or my colleague Matt Greig, on +44(0)2078013384 or in the evenings on +44(0)7918679405, alternatively, you can send a full CV to CV@advregulatory.com and one of us will contact you by return.
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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 team know our 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.

We provide a high level of service because we believe this matters.

Contact us today to see how we can help you, make that next career move on

+44 (0)20 7801 3380 

All applications are kept in confidence and we invite applications from all members of the Academic, Research & Development based bio-/pharmaceutical community.

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