Expiry Date: 30-09-2023
Category Regulatory Affairs
Job Type: Full Time
We are currently working with a highly regarded Global Biotechnology company in Raleigh, NC that is experiencing growth due to its exceptional early and mid-stage development pipeline of biologicals/mAbs and Cell and Gene Therapy products. This company also boasts two major blockbuster products.
Our client is expanding in several areas including Regulatory Affairs and is offering real opportunities to lead early development OR mid-and-late-stage development indications and the following NDA/BLA before potentially moving into a Global role as a director. We have positions open at both RA Senior Manager and Associate Director grades.
The roles are all in regulatory development, i.e. drug product development, clinical program development for drug, biologic, and drug/device combination products, regulatory application planning and execution, EOP1/2 mgs, 1st BLA and sBLAs, for new clinical indications. We are excited because the company is halfway through reinventing itself from wide-label drugs (both mAbs and NCEs) to a focus on rare diseases and genetic disorders. Their entry into rAAVs (Adeno Viral Vectors), silencing RNAs, and other novel recombinants has started. Sr Manager and Associate Director roles are for Reg US Liaisons for assigned indications. Both roles come with a great package and include a strong basic salary, an excellent bonus (approx. 20%), and LTIs for AD grade, as well a generous benefits package and real flexible working with options to be 100% remote available.
My client has a great 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 my client might be a good option.
If you have worked on early development compounds or led the strategic input for line extensions or NDAs (so 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.
We would be happy to talk through the details of the role to see if this would be an interesting next step for you!