Director, CMC Regulatory Affairs

Our Immuno-Oncology client just north of Boston, MA is looking to add a Director, CMC Regulatory Affairs to their team!  This role will oversee and direct all chemistry, manufacturing and controls (CMC) regulatory strategies for new and mature products. Provide guidance and support to internal groups such as Quality, Technical Operations, and Analytical as well as to outside groups such as contract manufacturing organizations to ensure that products are manufactured in compliance with all applicable regulations. Provide strategic input and risk assessments and oversees preparation of CMC regulatory submissions. Interacts with regulatory agencies. Selects, develops and evaluates personnel to ensure the efficient operation of the regulatory CMC function.  Other responsibilities included but not limited to: 

 

  • Develop overall CMC regulatory strategy for company’s products
  • Lead CMC regulatory strategy discussion and provide regulatory guidance to Technical Operations and Quality Assurance to ensure compliance with applicable regulations and guidelines.
  • Oversee and lead all regulatory CMC submission for the INDs, CTAs, BLAs, and NDAs.
  • Lead CMC related interactions with the health authorities including preparation of briefing documents.
  • Anticipate consequences of new or revised worldwide regulations and guidelines.
  • Prepare, review and approve applications for consistency with appropriate guidelines and regulations. Provide appropriate guidance and develop regulatory strategies.
  • Act as a recognized expert to internal working teams, external regulatory authorities and other regulatory affairs professionals.
  • Serve as primary regulatory contact and provide direction to CROs and contract vendors as needed.
  • Keep abreast of relevant technical literature.
  • Manage resources, administrative tasks, and maintain accurate records.
  • Verify that manufacturing activities are conducted in compliance with Federal regulations and protocol requirements.
  • Verify that the data submitted to Regulatory Agencies in support of Investigational New Drugs (INDs), Clinical Trial Applications (CTAs) or Marketing Applications are supported by adequate and relevant source documentation.
  • Report findings and risk assessment of deficiencies and deviations from company standards to the head of Regulatory Affairs.

 

Requirements: 

  • Bachelor’s degree (BA/BS) in a scientific discipline required and advanced degree preferred with a minimum of 8+ years’ experience in drug development/regulatory affairs.
  • Experience with both US FDA and EMA is required. Global experience is preferred.
  • Prior BLA and NDA experience is preferred.
  • Experience with the regulation of biologics and small molecule drug products is essential. Experience in gene therapy would be an asset.
  • A broad understanding of the drug product development process is required.
  • This position requires a thorough knowledge of U.S. Federal Regulations related to clinical research (21 CFR Parts 50, 56, 312), ICH Good Clinical Practice Guidelines, and an understanding of GLP and GMP requirements and guidelines (21 CFR 58, 210 and 211).
  • Demonstrated ability to independently review CMC related documents and reports.
  • Periodic travel of up to 15% can be expected, including international.