New Regulatory roles in RTP - Do you want to lead a BLA and then move into a Global role! Great pipeline, relaxed culture & flexible/remote working

Reference: JPC573

Expiry Date: 19-08-2023

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Durham County
United States

Apply for position

Job Description

We have new role with a North Carolina based Global Biotechnology client (with 2 major blockbuster products) that is expanding due to having a great early and mid-stage development pipeline of biologicals/mAbs and also some Cell and Gene Therapy products.


My client is expanding in a number of areas including Regulatory Affairs and are offering real opportunities to lead early and mid stage development indications and then the BLA before potentially moving into a Global role as a Director. We have positions open at both RA Senior Manager and Associate Director grade.


Both roles come with a great package for North Carolina, and includes a strong basic salary, an excellent bonus (approx. 20%) and LTI's for AD grade, as well a generous benefits package and flexible working with options to be 100% remote.


My client has a great a track record in developing regulatory staff and giving clear career pathways to team leadership or global project responsibility, so whether you want to develop your strategy skills and eventually broaden your focus, or you want to move to management over the next few years, this is definitely an organization to consider.


If you have worked in early development compounds or led the strategic input for line extensions or NDAs (late phase to readout, or pre-submission to approval, ideally), or alternatively, have a mix of early and late phase development, including preparation of INDs, Brochure and Briefing documents, Pre-IND, EOP2 meetings, Pediatric or Orphan studies then my client would find your profile very interesting.


To Apply!

If you are interested in hearing more about this or other roles in Medical Writing, please contact me, Theo Moore on 587.216.9302 or via email, or my colleague Ivan Nash on 908.378.8980.