VP of Regulatory Affairs CMC - Exciting Gene Therapy Portfolio - Team Mngt - ** Viral Vector, RNA, and ASOs ** Remote with HQ in Cambridge, MA

Reference: TM150422D

Expiry Date: 03-08-2022

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Middlesex County
United States

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Job Description

ADV Talent Partners have an exciting and unique opportunity at VP grade in the Cell & Gene Therapy space for an exciting company with a great Regulatory Leadership team.

My client already has several products already approved, over 1 billion in cash reserves and a strong portfolio of Gene therapy products in early and mid-development. The HQ is based in Cambridge, MA, but with the option for you to be remote and work from home.

This role is to join and lead their existing regulatory CMC team to manage several assets which are ATMP / new modality products based on Viral Vectors, and Oligos. You will lead a global group with both US and global responsibility for all NMEs in Ph 1 to 3, regulatory CMC input into Ph 3 scale up, pre-BLA build and BLA / EU MAA submissions for QoS and M3, as well as for eventual lifecycle. This will include CMC queries, FDA meetings & responses, EU Scientific advice, as well as for networking and policy involvement on a topical level.

This could be an exciting time to join, and you will be reporting into a highly experienced SVP, with many successful submissions to her name. Compensation packages are high level, with an excellent bonus and a lucrative stock plan - I think this is really great role, for indications with huge potential.

 

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me, Theo Moore, for this role by email to theo@advtalent.com or if you would like more information on the role, on US 908-348-6714. I will support you throughout the interview and on-boarding experience.

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