Regulatory Affairs CMC, Associate Director *** Cell & Gene/CRISPR-Cas9 *** Exciting & Varied Pipeline *** Remote with a great package!

Reference: SIT533

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

Location: US remote/home based (but working on EST)

We are working with an exciting Biotech and Cell and Gene Therapy company with a unique and rather special portfolio of mixed products and modalities, across a range of high-profile therapy areas and rare diseases, mostly still in early stages of development (P1/P2).

My client is well established in the CGT sector and is consistently voted as one of the best places to work. They have a mixed and diverse working environment always focused on inclusion and collaborative working. The culture is built around offering new opportunities for development, training, growth, and with big(ger) plans for growth in 2023, this is a great time to be part of a company making history using CRSPR technology, as they continue to develop both in-vivo and ex-vivo treatments.

As the Regulatory Affairs CMC Associate Director, you will lead and/or support the development of a number of innovative cell-based gene therapy products, providing strategic CMC regulatory advice, communicating regulatory risks, and managing CMC submissions/communications with health authorities. You will also help define CMC content requirements for the quality sections of regulatory dossiers (IND/CTA/BLA/NDA).

The role reports into a hugely experienced Head of Regulatory CMC, with extensive knowledge and achievements within the Cell and Gene Therapy sector, who is also super supportive and keen for his team members to feel challenged and independent, but always as part of group.

The ideal candidate will have worked in Cell and Gene, Advanced Therapies, RNA, ATMP’s, Adeno’s or CRISPR and have experience of providing Regulatory CMC leadership and supporting interactions with regulatory health authorities and submitting CTA/IND’s as required. You will have strong knowledge of current Good Manufacturing Practices (GMP), drug and biologics development regulations and guidelines including ICH, FDA and EMA guidelines is a must.

On offer is a terrific package, including a strong basic salary, competitive bonus and extremely remunerative LTI/RSU package, with a range of extra benefits including excellent health insurance, a 401k match, company shutdowns, good PTO’s and much more.


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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