Expiry Date: 28-12-2022
Categories Biotech, Regulatory Affairs
Job Type: Full Time
We have an exciting new role we are working on for a Regulatory CMC professional experienced in Cell and Gene Therapies who now wants to take a key role in a number of high profile BLA and MAA’s planned/scheduled in the next 12-18 months as the Director Regulatory Affairs CMC.
Our client is a real pioneer in Cell and Gene Therapy. Their HQ is based in MA, but they are happy to have this role as fully remote and they already have successfully commercialized ATMP products on the market and have a decent pipeline of late-stage indications. The senior Regulatory and R&D leadership teams are well established and are highly experienced in Cell and Gene therapy, and our client company is financially secure.
This will be a full project lifecycle role, and includes development projects, BLA/MAA’s and also global lifecycle activities for recently approved products (US & EU) and now ready for global submissions. The Global Regulatory CMC department provides Chemistry, Manufacturing and Controls (CMC) related regulatory expertise for development and commercial stage cell and gene therapy products, develops strategies and partners with key stakeholders to execute on the strategies in alignment with business priorities.
This role would suit you if you are:
A strong salary and extensive benefits package are available including a good stock plan and there is full flexibility to work remotely.
If you think your profile would make you an ideal candidate for this position, then please contact Theo Moore or Roland Schnapka on 908.348.6714 or send your CV in confidence to CV@AdvTalent.com and we will quickly get in contact with you!
If this role isn’t quite for you but you are open to something new, we would welcome to discuss other roles we have open in the Cell and Gene therapy space.
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