Senior Manager, Regulatory Affairs (Biotechnology)

Location: South San Francisco, United States; hybrid 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 therapies for genetically validated cardioendocrine diseases, including severe hypertriglyceridemia and acromegaly.

What you will do

• Formulate regulatory strategies for assigned programs and support US and international development plans.
• Coordinate, prepare, review, and submit regulatory documents and filings across regions.
• Prepare responses to queries from FDA, EMA, and other regulatory authorities.
• Collaborate with cross-functional teams, external partners, vendors, and health authorities to manage regulatory risks, goals, and timelines.
• Ensure compliance with regulatory commitments, including IND and CTA commitments.
• Provide regulatory guidance, support due diligence, and develop operating guidelines and common practices.

Requirements

• Bachelor’s degree required, preferably in a scientific field; an advanced degree is advantageous.
• 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, FDA/EMA regulations, and ICH guidelines.
• Experience with clinical-trial regulatory requirements, regulatory submissions, eCTD, and electronic submissions.
• Working knowledge of discovery, development, and manufacturing processes.
• Excellent cross-functional communication, organization, and attention to detail.

Nice to have

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

Culture & Benefits

• Collaborative, hands-on environment with close involvement across organizational levels.
• Opportunity to work with clinical-stage therapies approaching Phase 3 and progressing through Phase 2/3 development.
• Full-time position with a competitive salary aligned with experience, qualifications, and responsibilities.