This late-stage biotechnology company is developing first-in class T Cell based cancer immunotherapies. They are seeking a Vice President of CMC Regulatory who can lead all aspects of CMC Regulatory for their development programs and approved products. Reporting into the EVP of Regulatory, you will provide strategic and operational leadership, and ensure the effectiveness of the CMC Regulatory team. This role is remote with some regular travel. With their lead candidate in Phase 3, this company offers innovative science, competitive compensation and a patient-focused company culture. This role is remote with some regular travel. Now is an exciting time to join this innovative organization and improve the lives of patients in need!
- Lead the development and implementation of all CMC regulatory strategies to support global development programs, and market applications for cell therapies.
- Responsible for ensuring the appropriate execution of CMC regulatory strategy.
- Ensure the effectiveness of the CMC Regulatory team in developing submissions and in working across functions.
- Oversee all CMC-related submission planning and execution, ensuring that high‑quality and accurate submission documents are completed within target timelines.
- Accurately interpret and discuss data within cross-functional teams and with health authorities.
- Actively seek out knowledge of overall corporate planning and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge into submission planning.
- Lead the preparation of risk assessments on CMC regulatory topics.
- Build and manage relationships through active partnering with key internal and external stakeholders.
- Ensure CMC dossiers meet ICH format and content requirements, as well as specific local requirements of individual countries.
- Stay current with regulatory requirements and initiate process improvements as appropriate.
- Analyze and exercise judgment on complex issues, guided by a thorough understanding of CMC.
- BS degree in Biochemistry, Biology, Chemistry, Engineering or related field required; advanced degree preferred.
- 20+ years of biopharmaceutical industry experience; with 15+ years of relevant biologics experience in Regulatory CMC. Cell therapy experience a plus.
- Demonstrated track record of successful submissions to FDA and/or other health authorities, including EMA.
- Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions.
- Extensive regulatory team management experience and in developing innovative regulatory solutions
- Ability to motivate and lead others
- Excellent interpersonal, verbal and written communication skills as well as the ability to effectively lead and influence others are essential in this collaborative work environment.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Excellent organizational and planning skills.
- Ability to build positive relationships with co-workers of various backgrounds and expertise.
- Must be a collaborative team player who is comfortable wearing many hats in a small biotech environment.