Associate Director or Director, Cell Therapy Regulatory – Boston, MA or Remote

Reference: SIT540

Expiry Date: 25-05-2023

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Suffolk County
United States
Remote Working

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Job Description

There are so many facts about this R&D organization as to why they are highly tipped for success and make a compelling opportunity for an up and coming Associate Director or Director of Regulatory:

  • R&D unit is led by a Novel Laureate for her work on CRISPR technology – they have ex vivo and in vivo modalities and all novel MOAs.
  • Wide TA spread: Inherited, Rare and Chronic AI Diseases incl. Blood Cancers and Liver / Kidney Disease.
  • A healthy Market Cap of 3.25 Billion USD supporting their advancing pipeline: bringing in 4 new molecules / IND programs in 2023 into clinic, 3 in CTs already.
  • Strong Leadership Team, in regulatory and key partners including Clinical Development with a regulatory track record gained in both small and large pharmaceutical companies.
  • Depth and variety: you will work on different NMEs in different phases, ideally using your Cellular and Gene Therapy experience, combined with knowledge of early or late clinical development regulatory affairs.
  • High reward: the company give AD and Directors a massive sign on, in stock and bonuses, a 6 figure amount.
  • Smaller company, 500 FTEs, just under USD <700 Million in reserves: you will gain more visibility in this company than a medium or larger pharma!
  • Technology: the company is well primed and has both a strong technical regulatory and MSAT / CMC group, so you can focus on the other modules without being swamped on CMC Regs.

About My Client:

My client is a growing Biotech with two platforms, for in vivo and ex vivo, with around 10 major programs in late discovery and early clinical development, and are now seeking a committed, enthusiastic individual with a high capacity for learning and growing, to join a regulatory team led by a capable group of senior leads and managers.

About the Role:

You will support IND programs, brochure development, scientific advice meetings and with a more senior person, accelerated or BTD regulatory submission strategies, for primarily the US and then European regions. You will have strong US experience and want to gain more global expertise. You will have already worked in Cell or Gene therapies or in Oncology or Haematology, alternatively, you might have worked in Small Molecules or Oligos for Rare Diseases.  Any of these options is relevant to the role, but their technology is as described and very cutting edge.


The company is HQ’d in Massachusetts area, and offer remote working, with regular visits to the HQ.

About the Package:

The company offer a six figure sign-on award which is truly impressive, an annual bonus, and an annual stock award (set each year by the senior LT).


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 send a full CV to and we will reply by return. We will support you throughout the interview and on-boarding experience.

GDPR & Data Protection: Your information is safeguarded for GDPR, and you will have the right to edit, amend or delete and ’’be forgotten’’ at any time after your initial registration.