Regulatory Project Manager/Senior Manager (Biotech)

Location: Hybrid role in South San Francisco, California, United States

Salary: $143,000–$175,000 annual base salary for employees located in the San Francisco Bay Area, plus eligibility for an annual performance bonus.

Company

hirify.global is a clinical-stage biopharmaceutical company using human genetics to develop precision medicines for kidney and metabolic diseases.

What you will do

• Maintain integrated plans and timelines for regulatory activities, health authority interactions, IND amendments, annual reports, clinical milestones, and future submissions.
• Partner with Medical Writing to track document development, review cycles, comment resolution, approvals, and readiness dates.
• Coordinate contributors across Regulatory, Clinical, Technical, Quality, and external partner teams.
• Track actions, owners, deadlines, dependencies, decisions, risks, and follow-ups across multiple workstreams.
• Identify bottlenecks, resource constraints, timeline risks, and readiness issues, escalating them appropriately.
• Prepare agendas, meeting summaries, dashboards, status updates, project trackers, templates, and practical working practices.

Requirements

• 5+ years of project management experience in the biopharmaceutical industry, supporting Regulatory Affairs, clinical development, or regulatory submissions.
• Bachelor’s degree in a scientific, health-related, or business discipline.
• Working knowledge of drug development and regulatory processes, including health authority interactions, IND maintenance, and clinical development milestones.
• Experience creating and managing project plans, timelines, trackers, dashboards, meeting agendas, and status updates.
• Strong organizational judgment, attention to detail, communication, and cross-functional collaboration skills.
• Ability to work in a hands-on, fast-paced biotech environment with internal stakeholders and external partners.

Nice to have

• Advanced degree or project management certification.
• Proficiency with common project management tools.

Culture & Benefits

• Mission-driven environment focused on developing precision medicines for patients with severe genetic diseases.
• Collaborative culture emphasizing resilience, initiative, integrity, calculated risk-taking, and team-first execution.
• Medical, dental, vision, and mental health benefits for eligible employees.
• Equity incentive plan and 401(k) program with employer match.
• Generous holiday and paid time off policy.