Director US Regulatory Strategy (Biopharmaceutical)

Location: Deerfield, Illinois, United States. Travel of up to 20% domestically; international travel may be required.

Salary: $200,000–$230,000 annually, plus eligibility for a 25% bonus target and participation in the long-term incentive plan.

Company

hirify.global is a global biopharmaceutical company focused exclusively on brain health and neurological and psychiatric diseases.

What you will do

• Lead US and global regulatory strategies for assigned drug and biological products through development, approval, and lifecycle management.
• Oversee the creation and assembly of investigational and marketed product registration packages for the US FDA.
• Liaise with the FDA on drug development, approval, and post-approval activities.
• Provide regulatory advice for clinical studies and marketing approvals and assess scientific data against regulatory requirements.
• Serve as the primary regulatory contact for assigned alliance product brands and coordinate governance meetings.
• Lead and develop cross-functional regulatory teams spanning CMC, Regulatory Operations, US Labeling, Promotion Compliance, Scientific Messaging, and International Regulatory.

Requirements

• Accredited bachelor's degree.
• 10+ years of experience in the pharmaceutical, medical device, or biotech industry, including 7+ years in Regulatory Affairs.
• Experience supporting both small-molecule and biological products and ensuring regulatory compliance.
• Regulatory management and team leadership experience in cross-functional, matrixed, hybrid, and multinational teams.
• Successful experience with FDA interactions and investigational and marketing application management and approvals.
• Excellent strategic, tactical, written, oral, and cross-functional communication skills, with the ability to navigate complex regulatory and compliance strategies.

Nice to have

• Bachelor's degree in life sciences.
• Master's, doctorate, MBA, or other professional certifications.
• Experience with the FDA and exposure to international regulatory affairs and ex-US submissions.

Culture & Benefits

• Mission-driven work focused on advancing brain health and transforming lives.
• Flexible paid time off.
• Medical, dental, and vision benefits.
• 401(k) with company match.
• 25% bonus target eligibility and participation in the long-term incentive plan.