Manager, Regulatory Affairs (Cell Therapy)

Location: Redwood City, California, United States; onsite attendance required at least three days per week, with Tuesday–Thursday mandatory.

Salary: $130,000–$179,000 USD annually, plus annual cash bonus and long-term incentives.

Company

hirify.global is a clinical-stage biotechnology company developing allogeneic gamma delta T-cell therapies for autoimmune diseases and cancer.

What you will do

• Manage global regulatory CMC implementation for assigned cell therapy projects across early- to late-stage development.
• Drive regulatory timelines, milestones, submissions, commitments, and change amendments.
• Author and review CMC documents and support FDA and ex-US agency meeting materials, including pre-IND and End of Phase meetings.
• Review CMC, clinical, and nonclinical documentation for GxP and regulatory compliance.
• Maintain regulatory databases covering submissions, agency communications, commitments, and information requests.
• Communicate changes in global regulations and guidance to cross-functional teams and develop electronic CTD publishing skills.

Requirements

• At least eight years of Regulatory Affairs experience in the biotechnology or pharmaceutical industry, including five years of Regulatory CMC experience.
• Experience with FDA and/or ex-US submissions and understanding of INDs, CTAs, DMFs, ARs/DSURs, FT/RMAT/BTD, and amendments.
• Bachelor’s degree in life sciences, pharmacy, or a related field; an advanced degree is preferred.
• Knowledge of FDA and EMA statutory frameworks, regulatory guidance, and product development.
• Excellent written and verbal English communication, planning, organization, problem-solving, and teamwork skills.
• Previous experience in quality assurance, analytical testing, manufacturing, and research is preferred.

Culture & Benefits

• Collaborative, high-performing work environment with a strong focus on in-person engagement.
• Base salary supplemented by annual cash bonus, equity incentives, ESPP, and a 401(k) with Roth option and 4.5% company match.
• Medical, dental, vision, FSA, HSA matching, life, disability, legal, pet, and other insurance programs.
• Paid time off, company holidays, winter break, sick time, and paid parental leave.
• Onsite gym, parking with electric vehicle charging, Caltrain shuttle, subsidized lunches, and stocked breakrooms.