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Director of Regulatory Affairs, CMC

Industry: Life Sciences

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Director of Regulatory Affairs, CMC

My client, located in central New Jersey, is a privately held drug discovery company focusing on small molecule compounds. They are well funded and aggressively looking to add this key member to their team. Reporting in the Vice President of Regulatory Affairs, the Sr. Director will be a strategic addition to move multiple compounds towards NDA. If you are interested in working with an organization that has a strong pipeline and you thrive in a scientific environment, this is the opportunity for you.

Job Responsibilities:

  • Lead CMC team in creation of CMC submissions (IND, NDA, post approval supplements, etc.)
  • Provide regulatory guidance on development/post-approval projects.
  • Define CMC Regulatory submission strategies
  • Responsible for direct Regulatory agency communication on all CMC related issues
  • Collaborates with cross functional project team members in preparation for meetings/hearings with Health Authorities
  • Liaise with CMO’s, QA, corporate partners and other regulatory personnel
Job Requirements:

  • B.S. in Chemistry, Biology or Pharmaceutical Science (advanced degree preferred)
  • 10+ years CMC related experience
  • Expert knowledge and understanding of applicable regulations, guidelines, etc. relating to international phase I-IV drug development and NDA/MAA successful filing
  • Experience working with electronic document management system

Location: Princeton, NJ & New York City, NY

 

For confidential consideration, please forward your resume in a Word document to jharris@kleinhersh.com only qualified candidates will be contacted.

Visit http://www.kleinhersh.com/ to view other job opportunities available through our company.

For additional information about this job, please contact: jharris@kleinhersh.com