BioSpace
Manager, Regulatory Affairs
Adicet Bio, Inc. is a clinical‑stage biotechnology company discovering and developing allogeneic gamma‑delta T cell therapies for autoimmune diseases and cancer. The company is advancing a pipeline of “off‑the‑shelf” gamma‑delta T cells engineered with chimeric antigen receptors (CAR) to facilitate durable activity in patients.
Responsibilities
Support the regulatory function in assigned projects to drive global regulatory strategy.
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 submissions are of high quality.
Support the preparation and conduct of agency meetings, including briefing package coordination.
Review clinical and CMC documentation—including protocols, reports, DSURs, investigator brochures, change controls, certificates of analysis—to ensure GxP and regulatory compliance.
Create and maintain regulatory timelines and track deliverables to meet submission deadlines.
Interface with functional areas, external partners and consultants as required.
Maintain knowledge of current global regulations and guidance governing drugs and biologics in all phases of development.
Qualifications
Strong scientific background with a BA/BS in life sciences, pharmacy or related fields; advanced degree preferred.
At least five years of experience in Regulatory Affairs within the biotechnology or pharmaceutical industry.
Experience in quality assurance, analytical testing and research.
Knowledge and experience in interpreting regulations and guidelines related to drug and biologics development.
Desire and ability to work in a fast‑paced, start‑up environment.
Strong collaboration, teamwork, organizational skills, and attention to detail.
Excellent written and verbal communication skills.
Pay Range: $124,000–$171,000 USD
Adicet fosters a collaborative, high‑performing environment and offers a comprehensive benefits package, including base salary, annual cash bonus, long‑term equity incentives, 401(k) with Roth and company match, health, dental, vision, and flexible spending accounts, paid time off, and onsite wellness amenities.
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Responsibilities
Support the regulatory function in assigned projects to drive global regulatory strategy.
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 submissions are of high quality.
Support the preparation and conduct of agency meetings, including briefing package coordination.
Review clinical and CMC documentation—including protocols, reports, DSURs, investigator brochures, change controls, certificates of analysis—to ensure GxP and regulatory compliance.
Create and maintain regulatory timelines and track deliverables to meet submission deadlines.
Interface with functional areas, external partners and consultants as required.
Maintain knowledge of current global regulations and guidance governing drugs and biologics in all phases of development.
Qualifications
Strong scientific background with a BA/BS in life sciences, pharmacy or related fields; advanced degree preferred.
At least five years of experience in Regulatory Affairs within the biotechnology or pharmaceutical industry.
Experience in quality assurance, analytical testing and research.
Knowledge and experience in interpreting regulations and guidelines related to drug and biologics development.
Desire and ability to work in a fast‑paced, start‑up environment.
Strong collaboration, teamwork, organizational skills, and attention to detail.
Excellent written and verbal communication skills.
Pay Range: $124,000–$171,000 USD
Adicet fosters a collaborative, high‑performing environment and offers a comprehensive benefits package, including base salary, annual cash bonus, long‑term equity incentives, 401(k) with Roth and company match, health, dental, vision, and flexible spending accounts, paid time off, and onsite wellness amenities.
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