Senior Director, Regulatory Affairs, Global Regulatory Lead - Development Strategy

Location: Fully remote, performable from anywhere; occasional domestic and international travel of approximately 20% is expected. The listed office location is Bridgewater, New Jersey, United States.

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

• Lead global regulatory strategies for clinical, pre-clinical, and lifecycle management activities.
• Identify regulatory risks and define mitigation strategies across assigned programs.
• Advise cross-functional R&D teams on US IND and global CTA submission strategies.
• Direct planning and coordination of multinational clinical trial applications, briefing packages, and global marketing applications.
• Oversee preparation, review, and delivery of regulatory submissions and agency meeting materials.
• Serve as the global regulatory lead and primary regulatory contact for the US FDA while collaborating with regional leads and cross-functional teams.

Requirements

• Bachelor’s degree in life sciences or a related field.
• 8+ years of experience in Regulatory Affairs with hands-on submissions experience across the US, EU, and/or other international markets.
• Strong knowledge of global regulatory requirements and eCTD submission formats.
• Experience managing complex regulatory deliverables across product lifecycle stages.
• Strong submission writing and review skills, with significant experience interacting with the FDA, EMA, and other regulatory agencies.
• Deep understanding of the drug development process and ability to manage tight deadlines in a matrix environment.

Nice to have

• Advanced degree such as MS, PhD, or PharmD.
• Experience with orphan drug products.
• Experience with inhalation products.

Culture & Benefits

• Fully remote work with support for staying connected to the team and community.
• Medical, dental, vision, and mental health coverage, plus annual wellbeing reimbursement and an Employee Assistance Program.
• 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, LinkedIn Learning, workshops, leadership development, mentorship, employee resource groups, and service opportunities.