Director, Regulatory CMC, Cell and Gene Therapy - Support a BLA & MAA planned in the next 12 months – Fully Remote (FL)

Reference: ODT513J

Expiry Date: 28-12-2022

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Hillsborough County
United States
Remote Working

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Job Description

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:

  • An AD who wants to move up to Director grade OR an established Director, who wants to lead/support BLA’s and MAA’s planned in the next 12 months
  • A strong Regulatory CMC professional, who likes to “jump in” and get involved, sharing the workload with a strong team
  • A Regulatory CMC professional, who has some ATMP experiences in early development, but now wants late-stage submissions experience
  • Somebody who can plan, author, review and submit high quality CMC modules of investigational and marketing authorization filings for Cell and/or Gene Therapy products
  • Somebody with the ability to prioritize and respond effectively to program changes; work in a cross-functional team environment and with remote teams; with strong attention to detail and the ability to handle multiple tasks in parallel.

Experience needed:

  • Experience of leading Module 3 sections for investigational and marketing applications for biotech/ATMP products. US BLA experience highly preferred, including experience in the preparation of modules, leading adjudications of comments, responding to FDA BLA review Information Request and any associated regulatory program management
  • In-depth understanding of manufacturing, testing and regulation of biotechnology and/or gene therapy products for human use required
  • Successful experience authoring CMC documents, leading health authority oral/written communications and leading CMC-focused meetings is a must.

A strong salary and extensive benefits package are available including a good stock plan and there is full flexibility to work remotely.

 

To Apply!

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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