Director US Regulatory Strategy

Location: Remote/commuter opportunity for candidates within the United States; strong preference for Deerfield, Illinois. Remote-based candidates must travel to Deerfield as required, in addition to up to 20% domestic travel and possible international travel.

Salary: $200,000–$235,000 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, neurological diseases, and psychiatric diseases.

What you will do

• Lead US and/or global product registration strategies for assigned products.
• Coordinate cross-functional development teams and governance for US products.
• Oversee documentation for investigational and marketing registration packages submitted to the US FDA.
• Manage interactions with the FDA across drug development, approval, and post-approval activities.
• Provide regulatory advice for clinical studies and marketing approvals while assessing scientific data against regulatory requirements.
• Lead and develop a dotted-line regulatory affairs team covering CMC, regulatory operations, US labeling, promotion compliance, scientific messaging, and international regulatory affairs.

Requirements

• Accredited bachelor’s degree.
• 10+ years of R&D experience in the pharmaceutical or biotechnology industry, including 7+ years in Regulatory Affairs.
• Experience supporting both small-molecule and biological products and ensuring regulatory compliance.
• Regulatory management experience, directly or indirectly, with a record of compliant investigational and marketing application management and approvals.
• Successful experience with face-to-face, hybrid, and/or virtual FDA interactions.
• Ability to lead multinational, matrixed, and cross-functional teams, communicate strategic and tactical issues, and navigate complex regulatory strategies.

Nice to have

• Bachelor’s degree in life sciences.
• Master’s, doctorate, MBA, or professional certifications.
• Additional FDA experience and exposure to international regulatory affairs, including ex-US submissions.
• Based in or able to regularly travel to the Deerfield, Illinois office.

Culture & Benefits

• Purpose-driven work focused on advancing brain health and transforming lives.
• Flexible paid time off.
• Medical, dental, and vision benefits.
• Company-matched 401(k).
• Long-term incentive plan eligibility.