Manager, Regulatory Affairs CMC (Biologics / Gene Therapy)

Location Raleigh
Discipline: Regulatory Affairs
Job type: Permanent
Salary: £Salary: Negotiable
Contact name: Chris Sinclair

Contact email:
Contact phone: 1 617-982-1238
Job ref: 21410
Published: about 1 month ago
Expiry date: 09 May 2021

Location: Raleigh, NC

Our client are a very exciting global organisation that have been growing their US footprint over the last 12 months. Specializing in the Gene-editing domain to create solutions to treat cancer patients, this is a fantastic opportunity for the right individual to be the Regulatory CMC subject matter expert within the USA at the brand-new site in Raleigh.

You will be the first key Regulatory CMC hire in the USA and will be working with teams (internally and externally) located globally. This role offers fantastic variety and the chance to really make a mark on leading the Regulatory CMC strategy of the business with their new Raleigh manufacturing site.

Skills / Experience required:

  • 5+ years Regulatory Affairs experience in biological / biologics products (Cell / Gene therapy experience is preferred, but not necessary)

  • Strong knowledge of current regulatory best practices

  • Relevant experience with regulatory applications (IND / IMPD / BLA etc.)

  • Ability to work with global teams (internally and externally) – comfortable working independently within different time zones.

  • Educated (MSc, PhD, or PharmD) in the Life Science, Pharmacy or similar field.

If this sounds like the next step in your Regulatory career, please apply today so that Chris Sinclair can review your profile and be in touch to discuss this further.

Salary: Negotiable