Global Regulatory Leader ** Haemo / Oncology ** Fast Paced High Value Asset ** Morristown, NJ

Reference: SMM522A

Expiry Date: 12-01-2023

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Morris County
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Job Description

I recently placed the team leader in this well-known global Biotech & R&D Pharma Company, which has many firsts to their name, in terms of licensing first in class NMEs incl. nibs, mAbs and Cell & Gene therapies.

This role is one which will interest you if you want to work on a complex program, with a fast potential for an IMA, and where you will lead regulatory input into 1bs, 3a/b’s and take it into filing (rapidly) with follow-up studies. This role is not for the feint hearted, it is for someone who knows that BLA and MAA approvals is most expeditious pathway for growing your career!

The person I am hiring for, the line manager, I placed myself in this role and in her earlier career, so I can comfortably say I know this individual well, is very engaging, has the human touch, is a dedicated manager and previously as a Senior GRL led many well-known molecules to approval, the individual has a lot of experience to pass on to you!

The individual is now building up the team of GRLs, both in Switzerland and the USA, to lead NMEs in development and support new lifecycle.

Their pipeline is expanding, and this is without a doubt one of the main three companies in oncology, but in Haemo, they are marching forward. As part of this expansion, we are hiring for a Global Regulatory Leader who wants to lead the regulatory strategy and RA sub-team, in a company where GRLs are Directors, and Directors are rewarded and incentivised well.

To apply for this role, you will have direct or indirect US experience (with a US liaison if you were based in Europe), understand, and have expertise in leading faster development pathways, and know your haemo or solid tumor inside out. You will be a positive person, who is proactive, enjoys working with people and is willing to go above and beyond!


You can reach me, Matt Greig, to make an application on US 908 332 9157 or UK +44 207 801 3386 alternatively, why not email your CV to me at and my team and I will help you every step of the way.