Director (Lead) Global Regulatory Affairs CMC >> Remote on the East Coast, USA

Reference: JPC625

Expiry Date: 31-10-2023

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Middlesex County
United States

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Job Description

Adv Talent Partners are excited to present a brand-new Director, Global Regulatory Affairs CMC role with huge potential, where you can be involved in all stages of development from P1 to NDA for a Global pharmaceutical company, with a strong development pipeline and an established product portfolio marketed globally.

Our client company is an exciting organization to join. They are well established globally and have a number of exciting projects in development.

The current data on their pipeline programs in Phases 1 and 2 is very exciting and the role offers the opportunity to work on both small molecules and Oligonucleotides. The Head of Regulatory CMC is very passionate and committed, and highly experienced in CGT projects, for both early and late-stage development projects, and he will mentor and support you in decision-making and strategic input & leadership, ensuring you have a clear pathway for progression.

The teams on all levels consist of pro-active professionals dedicated to their field of work, who are all very welcoming of inspired and innovative newcomers, and the culture is focused on positive collaboration, and enjoying the challenge of being first to market.

By joining,

  • You will become the RA CMC Lead for your assigned NMEs which are all cutting edge and lead your own sub-team under the support and guidance of the line manager to BLA
  • You will get to drive adherence to CMC regulatory guidelines relevant to the development of both gene therapy and CAR-T products
  • You will lead the development of manufacturing strategies for the company’s therapeutics, including assessing proposed manufacturing process changes, providing strategic regulatory guidance, and participating in the development of regulatory processes and standards
  • You will be working under an exciting and highly regarded leadership team consisting of pioneering executives known for their breakthrough approach in Cell and Gene Medicines and Genome Editing
  • You will receive a strong total package including RSU’s, Stock Options, yearly bonus, and competitive basic salary; the benefits and holiday allowance are graded well and could be described as generous
  • The company is headquartered in Massachusetts, but the role is fully remote, to provide you with a quality work-life balance.

You will need to have RA CMC experience for IND’s in either CGT or for Biological projects and have led and/or supported a BLA.

To Apply!

To apply for this role, please contact me, Theo Moore on US 587.216.9302 or my colleague Ivan Nash on US 908 378 8980 or press the red “Apply for position” button or send a full CV to and we will reply by return. We will support you throughout the interview and onboarding experience.”