Director, Regulatory Affairs (Biotech)

Location: Remote-friendly within U.S. locations, with most work conducted from home and occasional travel to the Salt Lake City headquarters or other offices.

Annual base salary: $228,250–$280,720 in New York City, Boston, and the San Francisco Bay Area; $207,500–$255,200 in Salt Lake City and other U.S. locations. Additional annual bonus, equity compensation, and benefits are available.

Company

hirify.global is a clinical-stage TechBio company using AI, biology, chemistry, and clinical development technologies to discover and develop medicines.

What you will do

• Lead global regulatory strategies and activities for assigned products and programs across development and post-approval stages.
• Coordinate regulatory work across applicable jurisdictions, including the US, EU, and UK, while participating in global product team and Clinical Study Team activities.
• Manage complex regulatory issues, multiple projects, timelines, and program-level risk assessments.
• Develop and implement procedures and support regulatory submissions, including INDs, marketing authorization applications, orphan drug designations, pediatric submissions, and breakthrough designations.
• Review regulatory documents for consistency and quality, identify documentation gaps, and support successful registration and lifecycle management.
• Interpret regulatory guidance, prepare impact communications, and engage with health authorities and external stakeholders as needed.

Requirements

• At least 10 years of experience in the pharmaceutical industry, including at least 8 years in global regulatory affairs.
• Mandatory experience with major health authorities, including the US FDA, Health Canada, UK MHRA, and EMA.
• At least 8 years of experience with regulatory submissions such as INDs, NDAs/NDS/MAAs, post-marketing measures, PIPs/PSPs, ODD, BTD, and EU PRIME activities.
• Strong understanding of regulatory strategy and operational implementation.
• Outstanding management, communication, negotiation, interpersonal, organizational, and problem-solving skills.
• Experience working cross-functionally and on global teams.

Nice to have

• Experience in oncology, rare disease, or immunology and inflammation.

Culture & Benefits

• Remote-friendly work arrangement with most work performed from home.
• Occasional travel opportunities or expectations to company headquarters and other offices.
• Annual bonus, equity compensation, and comprehensive benefits package.
• Values-driven environment emphasizing integrity, accountability, active learning, urgency, and cross-functional collaboration.
• Opportunity to contribute to technology-enabled drug development and the future of regulatory science.