Regulatory Affairs CMC Associate Director ** Cell and Gene with CRISPR Technology ** Exciting Pipeline! ** Strong RA CMC leadership Team ** US Remote

Reference: SIM533R

Expiry Date: 28-02-2023

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Middlesex County
United States
Remote Working

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Job Description

Quick Facts:

  • MA or US Remote (the team keep Eastern Standard hours)
  • 3.5 billion Market Cap, founded by inventors in CRISPR tech
  • Spread of therapeutic indication; 4 NBEs in Clinic - 4 coming into Clinic 
  • All are ATMPs offering faster development pathways and data allowing FTD or BTD
  • Regulatory CMC team of 10 plus FTEs and is set to rapidly expand
  • This company are finding real, disease modifying cures in their TAs.

About This Opportunity

Wow, is what we have to say about this company, founded by several well-known people one achieving a Nobel Laureate for advancing CRISPR technology, and with the investment, people, and science in place for this company to be the next big name in Cell and Gene technology and wider, in Oncology therapies. Their research focus is spread out between inherited and autoimmune diseases and haematologic malignancies, and with their own IP and the alliances in place, the company is now under starters orders and preparing for rapid expansion.

There are no holes in this company’s game, you will see on us helping you apply to the company, that this is really quite a special outfit, you will be one of the first 500 people to join, and refreshingly, they have the money and joint development partners already in place so great data can be acted upon, trials can be started and the pipeline will advance quickly.

To help with their advancement of the portfolio the company are now hiring for a CMC Regulatory Associate Director, which can be based remotely in the USA, to be part of a functional team led by an individual who has already filed 3 BLAs for Cell and Gene therapies. You will work across many NMEs, so you will have a lot of variety and gain wider exposure to their ex vivo and in vivo molecules.

Your Experience

You will have worked on either IMPDs for Cell and Gene Therapies of any modality or have worked on a BLA build for a Cell or Gene Therapy, for US or global filings (M2.x / M3). You will be a great person to have around with a positive and pragmatic approach, being helpful and supportive. Willingness to come to site is useful for department meetings. The company is based in Cambridge, MA.

Stock and Remuneration

Associate Directors receive a six-figure stock award on joining, plus a decent bonus, annual LTIs and salary for this specislization. The role is open to anyone who is applicable on experience and wants to be part of what we believe will be a major player in the next generation of C&G therapies.


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 on-boarding experience.

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