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Job

Senior Director Regulatory CMC

  • Location

    New Jersey

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Tim Viola

  • Contact email:

    t.viola@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    about 2 months ago

  • Expiry date:

    2021-08-31

  • Startdate:

    ASAP

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 

Experience:

  • 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.

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