about 2 months ago
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.