Senior Director, Regulatory Affairs, Global Regulatory Lead (GRL) - Development Strategy (Biotechnology)

Location: Fully remote; can be performed from anywhere. Occasional domestic, international, and global travel of approximately 20% is expected.

Salary: $222,000–$303,000 annual.

Company

hirify.global is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.

What you will do

• Own and drive integrated global regulatory strategies for assigned development programs across the product lifecycle.
• Serve as the senior regulatory representative on Global Program Teams and influence indication, clinical development, evidence, pathway, and registration decisions.
• Lead regulatory interactions and negotiations with FDA, EMA, PMDA, and other Health Authorities.
• Align U.S., European, Japanese, and other regional regulatory strategies with global development objectives.
• Provide strategic direction for major submissions, clinical trial strategies, pediatric and orphan-drug strategies, and expedited development pathways.
• Identify regulatory opportunities and risks, communicate recommendations to senior leadership, and mentor regulatory colleagues.

Requirements

• Advanced degree such as MS, PhD, PharmD, or equivalent in life sciences or a related discipline.
• 10+ years of progressively responsible pharmaceutical or biotechnology regulatory affairs experience, including clinical development and global regulatory strategy.
• Experience serving as a Global Regulatory Lead or equivalent strategic regulatory leader for complex development programs.
• Extensive knowledge of regulatory requirements across the U.S., EU, Japan, and other major international markets.
• Significant experience leading interactions and negotiations with FDA, EMA, PMDA, or other major Health Authorities.
• Strong strategic thinking, negotiation, communication, judgment, and problem-solving skills in complex, uncertain development environments.

Culture & Benefits

• Fully remote work with connection to the hirify.global team and community.
• Medical, dental, vision, and mental health coverage, plus wellbeing reimbursement and Employee Assistance Program access.
• Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
• Learning programs, mentorship, employee resource groups, service opportunities, and recognition programs.