Director, Global Labeling Regulatory

Location: On site in Summit, New Jersey, United States; Monday–Friday during standard business hours, with manager-approved flexibility. Travel may be required for regulatory agency meetings, conferences, and manufacturing site visits.

Salary: $227,500–$250,000 annual base pay, plus eligibility for a discretionary bonus and equity award.

Company

hirify.global is a publicly traded biotechnology company developing cell and immunotherapy products, next-generation therapies, and vaccines for cancer and infectious diseases.

What you will do

• Develop and execute global labeling strategies from early clinical development through commercialization.
• Lead the preparation and maintenance of US Prescribing Information, EU Summary of Product Characteristics, packaging artwork, label proofs, and technical specifications.
• Ensure labeling content and artwork comply with FDA, EMA, MHRA, other international health authority requirements, and GMP.
• Coordinate label updates with manufacturing teams, internal groups, and third-party vendors.
• Oversee negotiations with regulatory agencies and prepare responses to labeling-related comments and questions.
• Manage labeling projects, change controls, team performance, hiring, training, and staff development.

Requirements

• Bachelor’s degree in life sciences or a technical discipline with 14+ years of relevant progressive experience, or a master’s degree with 12+ years.
• Extensive experience with global health authority labeling requirements for clinical and commercial-stage products.
• Expert knowledge of biologic-based drugs, including cell therapies, gene therapies, antibodies, and recombinant proteins.
• Strong leadership, problem-solving, decision-making, organizational, communication, and deadline-management skills.
• Experience working in complex matrix environments and proficiency with electronic document management systems.
• Must work on site in Summit, NJ.

Nice to have

• Experience preparing and submitting CMC modules in eCTD format.
• Experience managing staff.
• Experience with Veeva Vault.

Culture & Benefits

• Collaborative environment with cross-functional work across the company.
• Professional development opportunities in a growing biopharmaceutical organization.
• Medical, dental, and vision plan options, plus health and financial wellness programs.
• 401(k) retirement plan with company match, flexible spending accounts, disability coverage, and life insurance.
• Paid time off, holidays, education savings benefits, legal services, identity theft protection, and employee discounts.