Manager, Regulatory Affairs

Role Summary

Manager, Regulatory Affairs

Adicet Bio is seeking a highly motivated Manager, Regulatory Affairs, who is passionate in the field of cell therapy development for oncology and autoimmune patients. The role reports to the Regulatory group and focuses on developing regulatory strategies to support rapid clinical and product development of cell therapies, managing global regulatory implementation of assigned projects across early to late-stage development, and coordinating cross-functionally to meet program objectives.

Responsibilities

• Support the regulatory function in assigned projects to drive global regulatory readiness and submissions
• Provide regulatory strategy, guidance and input throughout product development
• Manage the preparation and filing of regulatory applications, commitments, and change amendments; author and review regulatory documents to ensure high-quality submissions
• Support the preparation and conduct of Agency meetings, including briefing package coordination
• Review clinical and CMC documentation (protocols, reports, DSURs, Investigator Brochures, change controls, certificates of analyses, etc.) to ensure GxP and regulatory compliance
• Create and maintain regulatory timelines and track deliverables to ensure submission timelines are met
• Interface with functional areas, external partners and consultants as needed
• Maintain knowledge of current global regulations and guidance for drugs and biologics across development phases

Qualifications

• Strong scientific background with BA/BS in life sciences, pharmacy, or related field; advanced degree preferred
• At least five years of experience in Regulatory Affairs in biotechnology or pharmaceutical industry
• Experience in quality assurance, analytical testing, and research is desirable
• Knowledge and experience interpreting regulations and guidelines related to drugs
• Ability to work in a fast-paced, startup environment
• Strong collaboration, teamwork, organizational skills, and attention to detail
• Excellent written and verbal communication