This late-stage biotechnology company is developing first-in class T Cell based cancer immunotherapies. They are seeking a Regulatory CMC Director (or AD) who can lead Regulatory CMC strategy and execution for multiple cell therapy programs in development and approved products. You will oversee the preparation and submission of high-quality CMC sections of INDs, CTAs, and BLAs and work closely with cross-functional teams and health authorities. This is a remote role! With their lead candidate in Phase 3, this company offers innovative science, competitive compensation and a patient-focused company culture. Now is an exciting time to join this innovative organization and improve the lives of patients in need!
Responsibilities:
- Provide regulatory CMC strategic leadership to support development of multiple T Cell based immune-oncology programs.
- Manage and implement planning, preparation and submission of high-quality CMC applications.
- Drive adherence to CMC regulatory guidelines relevant for the development of cell therapy products.
- Actively seek out knowledge of overall corporate planning and other factors that affect the CMC regulatory positions taken within the company and incorporate this knowledge into submission planning.
- Exercise judgment on complex issues by interpreting product data against Health Authority requirements.
- Deliver high-quality CMC submissions by taking ownership of assigned submissions and then working with functions to align on submission content.
- Ensure CMC dossiers meet ICH format and content requirements, as well as the specific local requirements of individual Health Authorities.
- Build and manage relationships through active partnering with key internal and external stakeholders.
- Proactively identify risks to submission timelines and content.
- Stay current with regulatory requirements and initiate process improvements as appropriate.
Knowledge and Skills:
- Bachelors in a scientific discipline; advanced degree (MS, PhD, Pharm D) preferred.
- Ten or more years of experience in Regulatory CMC for pharmaceutical drugs and biologics.
- Must have Regulatory CMC experience with cell therapy programs.
- Demonstrated track record of successful CMC submissions to FDA and/or other health authorities.
- Direct interactions with regulatory health authorities and experience with BLA/MAA filings.
- Experience in post-approval dossier life cycle management and direct interactions supporting health authority GMP inspections desirable.
- Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions.
- Strong organizational and planning skills.
- Proven ability to communicate effectively and efficiently cross functionally and with regulatory agencies.
- Ability to build positive relationships with co-workers of various backgrounds and expertise.
- Outstanding written and verbal communication skills.
- Must be a collaborative team player who is comfortable wearing many hats in a small biotech environment.
- Must be comfortable with ambiguity within an evolving company.