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Job

Manager/Director Regulatory CMC

  • Location

    New Jersey

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Tim Viola

  • Contact email:

    t.viola@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    about 1 month ago

  • Expiry date:

    2021-10-01

  • Startdate:

    ASAP

I am working with a large pharmaceutical client of ours who is looking for candidates to add to their teriffic regulatory CMC team. My client is looking for several candidates to add to their Cell and Gene Therapy team, and are hiring at a number of levels as they continue their growth in 2021.

Role: Manager/Director Regulatory CMC

Location: 2 days a week in NJ or MA office

Salary: Above Market Value + Bonus

Qualified candidates will have the following:

  • Experience authoring and reviewing CMC sections of IND, CTA, MAA, NDA or BLA
  • Experience within CMC cell/gene therapy
  • Experience dealing with direct reports
  • Working knowledge of US and global regulations
  • Experience with FDA and Global Health Authority interactions
  • 5-10+ years of experience wokring in a regulatory function

If interested, please apply directly or feel free to shoot me an email at t.viola@hamlynwilliams.com to set up a time to speak.

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