This clinical-stage immune-oncology company is developing gene and cell therapies for the treatment of blood cancers and solid tumors. They are seeking a Director (or Associate Director) of Regulatory CMC to develop and execute on regulatory CMC strategies for their pipeline of novel biologic programs. Reporting into the Head of Regulatory, you will work closely with cross-functional teams and contract manufacturing organizations to ensure adherence to regulations. This company offers competitive compensation, great benefits, and a collaborative company culture. Now is an exciting time to join this growing organization and help to get innovative oncology programs approved!
Responsibilities:
- Develop and execute CMC regulatory strategies for the company’s pipeline of immune-oncology programs.
- Oversee and lead all regulatory CMC submission for INDs, CTAs, BLAs and other filings.
- Provide regulatory guidance to Technical Operations and Quality Assurance to ensure compliance with applicable regulations and guidelines.
- Lead CMC related interactions with the health authorities including preparation of briefing documents.
- Anticipate consequences of new or revised worldwide regulations and guidelines.
- Serve as primary regulatory CMC contact, providing direction to CMOs, CROs and contract vendors as needed.
- 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 INDs, 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.
Qualifications:
- Bachelor’s degree in a scientific discipline required. Advanced degree preferred.
- 8+ years’ experience in CMC regulatory affairs for drug development.
- Regulatory CMC experience with biologics is required. Immune-oncology experience with cell or gene therapies is preferred.
- Experience working with both the US FDA and EMA is required. Broader global experience is desirable.
- Regulatory CMC filing experience with BLAs and NDAs.
- A broad understanding of the drug product development process is required.
- Thorough knowledge of U.S. Federal Regulations related to clinical research, ICH Good Clinical Practice Guidelines, and an understanding of GLP and GMP requirements and guidelines.
- Demonstrated ability to independently review CMC related documents and reports.
- Ability to work as an individual contributor and work well with cross functional teams.
- Must be able to thrive in a fast-paced biotech environment and work with external partners.