Accessibility Links

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:


  • 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


  • 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

Similar jobs
Associate Director / Director of Regulatory Affairs
  • Job type: Permanent
  • Location: San Francisco, California
  • Salary: Negotiable
  • Description Title: Associate Director/Director of Regulatory Affairs Location: South San Francisco, CA One of the Bay Area's exciting pharmaceutical companies is looking for an Associate Director or Director of
Document Control Specialist
  • Job type: Contract
  • Location: San Diego, California
  • Salary: Competitive
  • Description We are currently looking for a Document Control Specialist with a background in Quality Assurance. The company is small knit and they invest in their people and resources
Senior Regulatory Affairs Manager
  • Job type: Permanent
  • Location: Gothenburg
  • Salary: Competitive
  • Description Describe the job: A highly-innovative Mid-Size Medical Device company specialising in the field of Wound Care is seeking a Senior Regulatory Affairs Manager based in Gothenburg, Sweden
Medical Device Auditor
  • Job type: Permanent
  • Location: Munich, Bayern
  • Salary: Competitive
  • Description Medical Device Auditor Job type: Permanent Location: München Salary: €55,000 - €70,000 A leading global Medical Device Notified Body is currently seeking to hire an Auditor to join their dynamic
Regulatory Affairs Consultant
  • Job type: Permanent
  • Location: Germany
  • Salary: Competitive
  • Description Description: A global leading medical device organisation is in search of a Senior Regulatory Affairs Manager in the south of Germany, Frankfurt region. As a leading medical device provider and an