Sr Regulatory Affairs Manager ** Do you want to be part of a major MAA filing?

Location
Mainland Europe
Salary
On Application
Posted
15 Aug 2019
Closes
14 Sep 2019
Ref
MG/10407B R8
Contact
Matt Greig
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Sr Regulatory Affairs Manager ** Do you want to be part of a major MAA filing? In a company with the GRL pathway available ** Mainland EU

We are pleased to present you this role for a major bio-pharmaceutical company, where both the ideas of the GRL career pathway and working on a new MAA are part of this opportunity. You will be joining a successful company in a smaller team to focus on filing a MAA with multiple indications, a mAb, which is currently at the End of Phase 2 / Phase 3 where you will directly work with the GRL who is highly experienced and much liked.

So you will want to work in an organization where the GRL career pathway is open to you, but to get there you want to consolidate your experiences and build upon these by working on taking a NBE from Phase 3 into filing and review. So this will include preparing CTAs for submissions through CROs and the affiliates, preparing Scientific Advice / Pre Subs Meetings and Brochure packs for different indications and, for PIPs. After this, the team will work together to prepare the MAA (in a company where the CMC is done by another team).

The role can be graded Senior Manager / Manager and you will be part of a team where most of the GRLs and Team Managers started in a near identical roles, so they have managed to grow, and so will you, because the environment lends itself to sharing know-how and working collaboratively, where merit is rewarded.

You will have 2 of the following to be able to apply for this role:

  • Preparation of regulatory CTA submissions, Scientific Advice or PIPs
  • Preparation and / or filing of Line Extension New Indications
  • Early Phase regulatory work, whether for a CRO or Pharma Co
  • Regulatory coordination and management of Day queries or FUMs (follow up measures) even if you joined the project just post submission.

In return, my client will pay for a relocation including temporary housing and a settling-in allowance, plus a strong package including bonus, plus 48 days off a year and a top level health insurance package.

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To apply, please contact either myself Theo Moore on +44 (0)20 7801 3384 or my colleague Oli on +44 (0)20 7801 3388 or send a full CV to cv@advregulatory.com and we will respond by return. We are assigned these roles by our client and will provide you with support throughout the hiring process.
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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.

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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