Connecting linkedin



Senior Director Regulatory CMC

  • Location

    New Jersey

  • Sector:

    Life Sciences

  • Job type:


  • Contact:

    Tim Viola

  • Contact email:

  • Salary high:


  • Salary low:


  • Published:

    about 2 months ago

  • Expiry date:


  • Startdate:


My client is a regulatory consultancy out of the northern New Jersey area, looking to add a Senior Director of Regulatory CMC to their terrific team of consultants. 

Responsibilities will include:

  • Prepare or review CMC technical documents, CTD Module 2, 3 and Module 3 for submissions.
  • Review of CTD Module 2.3 and Module 3 for technical content and compliance with regulatory requirements.
  • Participate in the development of global CMC regulatory strategies. 
  • Manage novel compound contract manufacturing for drug substances and drug products 


  • 10+ years of experience within Regulatory CMC
  • Experience with IND preparation and IND amendments, NDA submissions and supplements and CTD format and electronic submissions.
  • Knowledge of CMC, FDA, EMA and ICH guidelines.
  • Experience working in Cell Therapy or Biologics preferred
  • Experience working in Oncology or Immunology preferred
  • Advanced Degree highly preferred
  • Analytical chemistry experience a plus.

My client offers a competitive salary, health care benefits, group life insurance and 401(k) plan.