Associate Director, Health Authorities (Biotech)

Location: On site in Summit, New Jersey, United States; Monday–Friday during standard business hours, with manager-approved flexibility.

Salary: $185,000–$203,500 annually, plus eligibility for a discretionary bonus and equity award.

Company

hirify.global is a publicly traded, commercial-stage biotechnology company developing immunotherapies, cell therapies, cancer vaccines, and treatments for infectious diseases.

What you will do

• Lead Health Authorities staff by delegating projects, setting timelines, hiring and training employees, and monitoring performance.
• Manage clinical regulatory submissions, including INDs, CTAs, NDAs, BLAs, MAAs, and related applications.
• Review clinical data, reports, summaries, and documentation for protocol, statistical, monitoring, and data-management compliance.
• Coordinate CROs, regulatory consultants, subject matter experts, and key opinion leaders throughout the submission lifecycle.
• Prepare and manage responses to Health Authority questions, assemble final submission packages, and maintain project plans and product-development road maps.
• Oversee SOP training, document version control, naming conventions, change tracking, and audit-ready electronic submission documentation.

Requirements

• Bachelor’s degree in life sciences or a technical discipline with 10+ years of relevant progressive experience; or a master’s degree with 8+ years; or a doctorate with 6+ years.
• Experience managing staff and directing professional teams.
• Experience preparing and managing clinical modules for submissions in eCTD format.
• Experience in medical writing and organizing responses to Health Authority information requests.
• Expert knowledge of Health Authority guidance, clinical research, Good Clinical Practices, regulatory requirements, and clinical documentation.
• Ability to work on site in Summit, NJ, manage multiple deadlines, and adapt to changing requirements.

Nice to have

• Experience with regulatory submissions outside the United States.

Culture & Benefits

• Collaborative environment with cross-functional work across scientific and business areas.
• Professional development opportunities in a growing biotechnology company.
• Medical, dental, and vision plan options, health and financial wellness programs, and an employee assistance program.
• Life, disability, flexible spending, legal, identity theft protection, pet insurance, and employee discount benefits.
• 401(k) plan with company match, 529 education savings program, paid holidays, and paid time off.