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Associate Director Regulatory Affairs-CMC

  • Job type: Permanent
  • Location: Boston, Massachusetts
  • Salary: US$140000 - US$160000 per year
  • Job reference: 196051/002_1536764419
  • Sector: EPM Scientific, Regulatory
  • Date posted: 12/09/2018

Job description

An innovative biopharmaceutical company in the Greater MA area is looking to bring on an Associate Director RA-CMC in a brand new role. This company has a robust pipeline that includes products within women's healthcare, regenerative medicine, and a few others. The responsibilities and qualifications of the role can be found below:

Responsibilities:

  • Lead oversight in all CMC submissions and ensure that submissions comply with applicable global regulatory requirements as well as company policies and procedures,

  • Be the interface for the FDA and International Health Authorities regarding all CMC matter

  • Prepare regulatory assessments of post-marketing manufacturing changes and in preparing the technical portion of INDs, NDAs, amendments, and supplements.

  • Contribute to the development of domestic and global regulatory strategy

Qualifications:

  • Minimum of 6-8 years of regulatory CMC experience

  • Bachelors Degree in a Life Sciences/relevant scientific discipline, advanced degree preferred

  • Ability to be hands-on and work in a fast-paced environment

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