Global Regulatory Leader ** High value assets in Oncology ** New Jersey Based

Reference: SMJ522C

Expiry Date: 07-02-2023

Categories Biotech, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Middlesex County
United States

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Job Description

Our client is a well-known global Biotech and R&D Pharma company, which has many firsts to their name, in terms of licensing first in class NMEs including nibs, mAbs and Cell & Gene Therapies.

We recently placed the team leader, who we are hiring for, and she is very engaging, has the human touch, is a dedicated manager and previously as a Senior GRL led many well-known molecules to approval, this individual has a lot of experience to pass on to you!

The role will be interesting for 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 Phase 1b, Phase 3a/b and take it into filing rapidly with follow-up studies. This role is to achieve the ultimate goal of regulatory, which is getting BLA and MAA approvals and to have a clear pathway for your career growth!

You will be part of the team of GRLs that we are helping to hire in both Switzerland (Lausanne area) and the USA (New Jersey), to lead NMEs in development and support new lifecycle.

Their pipeline on these therapy areas is expanding and this is without a doubt, one of the main three companies in oncology, but in Hematology, they are marching forward. As part of the 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 are rewarded and incentivized well.

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

Degree/Experience requirements:

Bachelor’s Degree required; advanced scientific degree preferred (Master’s, PhD, PharmD, BSN) with experience of leading either EU or US & EU regulatory strategies.

Package and relocation:

My client will buyout your losses including bonus and stock and they will provide you with a yearly stock plan that includes RSUs and share options. The role comes with a very good basic salary, car or car allowance, bonus and a full relocation package to cover all your expenses including disturbance allowances and logistics support.


To Apply!

You can reach me, Theo Moore, to make an application on my US direct dial 908 348 6714 or 587 216 9302 or alternatively, why not email your CV to me at and my team and I will help you every step of the way.

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