Manager, Regulatory Affairs
Adicet Bio, Inc
August 29, 2026
Remote friendly (Redwood City, CA)
United States
Corporate Functions
Manager, Regulatory Affairs
Key Responsibilities:
- Support regulatory CMC functions for assigned projects to drive global regulatory timelines and milestones throughout the product lifecycle.
- Manage preparation and filing of regulatory CMC submissions, commitments, and change amendments; author and review regulatory CMC documents.
- Assist senior RA staff with FDA and ex-US meeting materials (e.g., Meeting Requests, Briefing Books) including pre-IND, End of Phase, Scientific Advice.
- Review CMC, clinical, and nonclinical documentation (e.g., change controls, certificates of analysis, labels, study reports, protocols, DSURs, Investigator Brochures) to ensure GxP and regulatory compliance.
- Maintain and track company databases for regulatory submissions and agency communications, commitments, and information requests/responses.
- Interface with functional areas, external partners, and consultants.
- Maintain knowledge of global regulations/guidance for drugs and biologics and communicate changes to cross-functional teams.
- Develop publishing skills for submission of electronic CTD-compliant documentation.
Qualifications:
- Experience with FDA and/or ex-US submissions.
- Understanding of INDs, CTAs, DMFs, ARs/DSURs, FT/RMAT/BTD, and amendments.
- BA/BS in life sciences, pharmacy, or related field; advanced degree preferred.
- 8+ years in Regulatory Affairs in biotech/pharma; 5+ years in Regulatory CMC.
Core Competencies / Skills:
- Knowledge of FDA/EMA statutory framework and guidance procedures; strong scientific background.
- Strong verbal/written communication; Microsoft Office proficiency.
- Strong planning/organization; ability to manage multiple projects with tight timelines.
- Initiative, teamwork, and ability to work with minimal supervision; problem-solving and strategic thinking; attention to detail.
Onsite requirement:
- Onsite at least three days per week (Tuesday–Thursday mandatory).
Compensation/Benefits (as stated):
- Base salary range: $130,000–$179,000; bonus; long-term incentives (equity); ESPP; 401(k) with 4.5% company match.
- Comprehensive health plans; FSA; company-matched HSA; life/AD&D, short/long-term disability; paid time off (13 holidays, winter break, vacation, sick time, paid parental leave).
Key Responsibilities:
- Support regulatory CMC functions for assigned projects to drive global regulatory timelines and milestones throughout the product lifecycle.
- Manage preparation and filing of regulatory CMC submissions, commitments, and change amendments; author and review regulatory CMC documents.
- Assist senior RA staff with FDA and ex-US meeting materials (e.g., Meeting Requests, Briefing Books) including pre-IND, End of Phase, Scientific Advice.
- Review CMC, clinical, and nonclinical documentation (e.g., change controls, certificates of analysis, labels, study reports, protocols, DSURs, Investigator Brochures) to ensure GxP and regulatory compliance.
- Maintain and track company databases for regulatory submissions and agency communications, commitments, and information requests/responses.
- Interface with functional areas, external partners, and consultants.
- Maintain knowledge of global regulations/guidance for drugs and biologics and communicate changes to cross-functional teams.
- Develop publishing skills for submission of electronic CTD-compliant documentation.
Qualifications:
- Experience with FDA and/or ex-US submissions.
- Understanding of INDs, CTAs, DMFs, ARs/DSURs, FT/RMAT/BTD, and amendments.
- BA/BS in life sciences, pharmacy, or related field; advanced degree preferred.
- 8+ years in Regulatory Affairs in biotech/pharma; 5+ years in Regulatory CMC.
Core Competencies / Skills:
- Knowledge of FDA/EMA statutory framework and guidance procedures; strong scientific background.
- Strong verbal/written communication; Microsoft Office proficiency.
- Strong planning/organization; ability to manage multiple projects with tight timelines.
- Initiative, teamwork, and ability to work with minimal supervision; problem-solving and strategic thinking; attention to detail.
Onsite requirement:
- Onsite at least three days per week (Tuesday–Thursday mandatory).
Compensation/Benefits (as stated):
- Base salary range: $130,000–$179,000; bonus; long-term incentives (equity); ESPP; 401(k) with 4.5% company match.
- Comprehensive health plans; FSA; company-matched HSA; life/AD&D, short/long-term disability; paid time off (13 holidays, winter break, vacation, sick time, paid parental leave).