RA CMC Director – X-Train into Gene Therapy – Boston or East Coast Remote – BLA’s in 2023 and 2024

Reference: ODT513

Expiry Date: 22-11-2022

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Suffolk County
Съединени щати
Remote Working

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Job Description

We have a great opportunity available for a Regulatory Affairs CMC Director with experience of working in Biologicals (monoclonals, Vaccines, proteins, plasma products) to join a Gene Therapy company with a great pipeline, supporting BLA’s planned in 2023 and 2024. Full Training provided.

Location: Full Remote (Global HQ in Boston, MA)

Our client is an established and highly rated global biotechnology company dedicated to bringing transformative gene therapies to patients with serious and life-threatening orphan diseases. They have been seen as pioneers in the industry and already have 2 commercialised Gene Therapy products.

For the next wave of their expansion, they have several BLA’s and MAA’s planned over the next 18 months, plus the continued rollout of their global lifecycle initiatives of their existing marketed products. Which means they now have an opportunity open to join their Global Regulatory CMC department in a role that can be fully remote if you are on EST.

The Global Regulatory CMC team provides regulatory expertise for development and commercial stage gene therapy products, develops strategies and partners with key stakeholders to execute on the strategies in alignment with business priorities. You will plan, author, review and submit high quality CMC modules of investigational and marketing authorization filings for gene therapy products to major regulatory jurisdictions such as US, EU, and UK, in collaboration with partners from Technical Operations/CMC and prepare responses to questions and requests for information from regulatory authorities. It’s essential have experience.

My client would welcome applicants you have worked in Biologicals (IND’s/BLA’s) and now want to move into ATMPs or candidates who have worked in early or late development in Cell and Gene Therapy, but now would like to co/lead a new BLA or MAA.

On offer is a very competitive East Coast package that includes basic, bonus, LTI’s and may other interesting benefits for you and your family.


To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me, Theo Moore or my collegue, Roland Schnapka on US 908 348 6714, or send a full CV to theo@advtalent.com and we would be happy to discuss the role further and give you more information. As we know the hiring manager, we will support you throughout the interview and on-boarding experience.

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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