Senior Manager, Regulatory Affairs (Biotech)

Location: South San Francisco, United States; hybrid schedule with on-site work required at least three days per week

Salary: $180,000–$195,000 per year

Company

hirify.global is a clinical-stage biotechnology company developing genetically informed therapies for serious cardioendocrine diseases.

What you will do

• Formulate regulatory strategies for assigned clinical programs using current regulatory intelligence.
• Coordinate, prepare, review, and submit regulatory documents and filings across regions.
• Develop responses to regulatory authority queries and manage commitments such as IND and CTA obligations.
• Collaborate with cross-functional teams, external partners, vendors, and health authorities on regulatory goals, risks, timelines, meetings, and conferences.
• Provide regulatory advice to other functional areas and participate in regulatory due diligence.
• Develop regulatory operating guidelines and common work practices, with potential supervision of employees and contractors.

Requirements

• Bachelor’s degree required, preferably in a scientific field; an advanced degree is a plus.
• 8+ years of drug development experience, including 5+ years in regulatory affairs within the biotechnology or pharmaceutical industry.
• Strong knowledge of international regulatory requirements, GXP, clinical trial regulations, and regulatory submissions.
• Experience with discovery, development, manufacturing, eCTD requirements, and electronic submissions.
• Ability to work effectively across teams and with external partners, with strong communication, organization, and attention to detail.
• Ability to work on-site in South San Francisco at least three days per week.

Nice to have

• Experience in cardiometabolic, cardiovascular, or endocrinology therapeutic areas.
• Experience with international regulatory submissions and processes.
• Advanced scientific degree.

Culture & Benefits

• Collaborative, hands-on environment with contributions valued across all levels.
• Opportunity to work on clinical programs addressing serious cardioendocrine diseases.
• Role includes collaboration with scientists, clinical advisers, biopharma professionals, external partners, and regulatory authorities.