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Manager, Regulatory Affairs

Adicet Bio
Location
Redwood City, CA
Posted
24 days ago
Department
Regulatory
What they actually want (must-haves)
  • Experienced in FDA and/or ex-US submissions
  • Understand the general requirements of INDs, CTAs, DMFs, ARs/DSURs, FT/RMAT/BTD, and amendments
  • Strong scientific background with BA/BS degree in life sciences, pharmacy, or other related fields
  • At least eight years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industry
  • Five years of Regulatory CMC experience
  • Strong verbal and written communication skills
Nice to have
  • Advanced degree is preferred
  • Previous experience in quality assurance, analytical testing, manufacturing, and research
What the job really is

The Manager, Regulatory Affairs at Adicet Bio will oversee the global CMC regulatory implementation for projects in early to late-stage development, ensuring compliance with regulatory requirements. This role involves preparing and filing regulatory submissions, assisting in the development of meeting materials for regulatory agency interactions, and maintaining knowledge of current global regulations. The position requires collaboration with various functional areas and external partners to drive projects to completion in a fast-paced environment.

Benefits
  • Competitive compensation package including base salary, annual cash bonus, long-term incentives (equity)
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) with ROTH and a 4.5% Company match
  • Comprehensive health plans (medical, dental, vision, etc.)
  • Flexible Health and Commuter Spending Accounts (FSA)
  • Company matched Health Savings Account (HSA)
Things to weigh
  • Position requires onsite presence at least three days a week (Tuesday–Thursday mandatory)
  • Fast-paced and dynamic work environment may not suit everyone
Job score3.4/5
Benefits5/5
Freshness4/5
Career value4/5
Role clarity4/5
Pay transparency0/5

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