Regulatory Affairs Senior Manager x 2 – RTP, NC Based Relo Available – Develop into a GRL (NCEs, mAbs & ATMPs)

Reference: TM121121BR

Expiry Date: 30-06-2022

Categories Biotech, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Durham County
United States

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Job Description

We have 2 new Regulatory Affairs Senior Manager roles open for an expanding and highly successful Global Biopharmaceutical company where you will be working on primarily biologicals in development. What sets this company apart is how many Senior Managers have evolved into US Leads, then GRLs and the company, based on merit, promote this career path.  This is a great opportunity to work on both early development and late stage programs for biological products (mAbs and ATMPs) although they do support specialty meds that are small molecule, in a role that offers great opportunities for development, a supportive leadership team, and a stable work environment.

We have multiple roles open available:

  • Late Development: supporting a Blockbuster Biological product you will be driving the preparation of a global dossier for new indications and supporting the subsequent US regulatory submissions
  • EOP2 to P3 and BLA: supporting a Senior US liaison on 2 indications coming to the end of Phase 2 to be fast tracked through Phase 3 and into pre-BLA
  • Early Dev: supporting the early medicines working on NME’s in Phases 1 and 2 with the option of following these projects through.

Candidates need to have at least 3 years’ regulatory affairs ideally within development or pre-approval and have had exposure to some of the following:  Orphan Drug Designations applications, Paediatric Investigation Plans, IND’s, s/NDAs or NDA/BLA preparations, plus the ability to provide strategic roadmaps including timelines, feasibility assessments for nonclinical and clinical development, gap analyses and due diligence for product development.


To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me, Theo Moore, for this role by email to or if you would like more information on the role, on  US 908-348-6714. I will support you throughout the interview and on-boarding experience.

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