Director, Regulatory Affairs CMC (Bio) – Global role (US, EU, Japan and RoW) – Cambridge, MA or Remote

Reference: TM190522A

Expiry Date: 23-08-2022

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Middlesex County
United States
Remote Working

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Job Description

We have a new Director, Regulatory Affairs CMC role to work/lead/manage Global submission activities (US, EU, Japan and RoW) for a number of monoclonal antibody indications for New Applications and Line Extensions/New Formulations.

This is a broad-based and varied role for a dynamic organization that is growing and expanding both its molecules in development and its regulatory teams.

What's great about this role?

  • Small Regulatory CMC team of 14
  • Expansive role(s) and interesting projects and regions
  • Working on Monoclonal Antibodies
  • Reporting into a strong and experienced VP of Regulatory CMC
  • Varied portfolio of recently approved BLA’s and products in development
  • Highly successful Biotechnology company that also has ATMP’s in its pipeline
  • Flexible home/office working options (with major sites in Cambridge, MA and Greater Boston)
  • Great recent track record of successful BLA’s
  • Working cultural focused on inspiration, innovation and collaboration!

It’s an exciting time to join and you will be reporting into a highly experienced VP, with many successful global submissions to her name. Compensation packages are high level, with an excellent bonus and a lucrative stock plan.

We think this is really great role, for a company with a bright future with several indications with huge potential.

 

To Apply!

If you are interested this role or are open to something new in the Regulatory CMC space, please contact me, Theo Moore on Theo@AdvTalent.com or call US 908 348 6714 - We are available 8.30am to 6pm EST or can happily take a call over the weekend until 1pm EST. I will support you throughout the interview and on-boarding experience.

LinkedIn Profile: https://uk.linkedin.com/in/theo-moore-b33696a

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