Senior Manager Regulatory Strategy (US Regulatory Affairs)

Location: Remote or commuter opportunity for candidates within the United States; strong preference for the Deerfield, Illinois office. Remote employees must travel to Deerfield, Illinois as needed and travel approximately 5% domestically.

Salary: $165,000–$185,000 annually, plus eligibility for a 15% bonus target and participation in the long-term incentive plan.

Company

hirify.global is a global biopharmaceutical company focused on research, development, manufacturing, and commercialization of treatments for neurological and psychiatric diseases.

What you will do

• Develop and implement US regulatory strategies for assigned developmental and marketed drug and biological products.
• Review submission documentation for accuracy, regulatory compliance, and alignment with FDA requirements.
• Manage and support FDA submissions, including investigational and marketing applications and lifecycle maintenance activities.
• Act as the FDA contact and US regulatory subject matter expert for assigned products.
• Assess scientific data, labeling, regulatory risks, and changing US regulations to inform product development and approval strategies.
• Collaborate with global, cross-functional, and operational partners to resolve regulatory issues and improve compliance and departmental efficiency.

Requirements

• Accredited bachelor's degree required.
• 7+ years of experience in the pharmaceutical and/or biotechnology industry.
• 5+ years of direct experience in US Regulatory Affairs.
• Direct experience with US drug development, regulatory submissions, investigational and marketing applications, and lifecycle maintenance.
• Experience interpreting scientific data and regulations, identifying regulatory risk, and negotiating or resolving differences.
• Strong communication, organization, multitasking, independent work, and matrixed-team collaboration skills; proficiency with Microsoft Word, Excel, Adobe Acrobat, and regulatory electronic document management systems.

Nice to have

• Degree in science, chemistry, pharmacy, or a related field, or an advanced degree.
• Experience in biologic development.
• Familiarity with Chemistry, Manufacturing, and Controls requirements.
• Willingness to work from the Deerfield, Illinois office.

Culture & Benefits

• Meaningful work focused on advancing brain health and transforming lives.
• Flexible paid time off.
• Medical, dental, and vision benefits.
• Company-matched 401(k).
• Equal employment opportunity and reasonable accommodation support.