Sr Manager, Regulatory Affairs (Biopharma)

Location: United States, primarily Santa Monica, California. The role follows a hybrid schedule with two remote days and three onsite days per week. The Santa Monica office is expected to transition to El Segundo/Thousand Oaks in January 2027; the role may also be based in Foster City or Parsippany.

Salary: $143,225–$185,350 for other US locations; $157,590–$203,940 for the Bay Area.

Company

hirify.global is a biopharmaceutical company developing CAR T-cell and T-cell receptor engineered cancer therapies.

What you will do

• Develop and implement regulatory product strategies for assigned programs.
• Lead regulatory submissions for clinical trials and marketing applications, including IND, CTA, BLA, and MAA filings.
• Represent Regulatory Affairs on cross-functional development and regulatory project teams.
• Assess regulatory risks, define mitigations, and manage project timelines and deliverables.
• Prepare teams for FDA, EMA, and other health authority interactions and coordinate responses to information requests.
• Train, manage, and mentor regulatory affairs personnel while contributing to regulatory policy initiatives.

Requirements

• BA/BS with 8+ years of relevant experience, or MA/MS/MBA with 6+ years of relevant experience.
• Experience leading regulatory submissions and regulatory projects.
• Experience writing or updating processes and working in project teams.
• Knowledge of global regulations and regulatory guidelines, including FDA and EMA requirements.
• Experience with investigational drugs, late-stage development, marketed products, and health authority interactions.
• Strong organizational, documentation, communication, prioritization, and interpersonal skills.

Nice to have

• MS, PhD, or PharmD in a scientific discipline.
• Experience in Gilead therapeutic areas and different stages of drug development.
• Experience leading preparation for FDA pre-NDA/BLA, EOP2, advisory committee, or EU scientific advice meetings.

Culture & Benefits

• Flexible hybrid work policy with two remote days and three onsite days weekly.
• People leadership focused on inclusion, employee development, and empowerment.
• Eligibility for a discretionary annual bonus and stock-based long-term incentives may vary by role.
• Benefits may include medical, dental, vision, and life insurance, as well as paid time off.