Manager, Regulatory Project Management (Biotechnology)

Location: Hybrid role based in Somerset, New Jersey, United States; applicants must be authorized to work in the United States.

Salary: $110,706–$145,303 USD annual base pay, plus performance-based bonus and/or equity for eligible roles.

Company

hirify.global is a global biotechnology company developing cell and gene therapies, including CAR-T, TCR-T, and natural killer cell-based therapies.

What you will do

• Coordinate day-to-day project activities across Research, CMC, Quality, Regulatory Affairs, Clinical Operations, and external partners.
• Develop and maintain project timelines, action-item trackers, meeting agendas, minutes, dashboards, and leadership materials.
• Facilitate project meetings, track follow-ups, monitor progress, and escalate risks, delays, and resource constraints.
• Support IND submissions and other regulatory filings throughout the product development lifecycle.
• Track budgets, purchase orders, invoices, vendors, and resource utilization with Finance and Procurement.
• Maintain accurate project documentation and improve project management processes, templates, and best practices.

Requirements

• Bachelor’s degree in Life Sciences, Biotechnology, Biomedical Engineering, Pharmacy, or a related scientific field; a master’s degree is preferred.
• 1–3 years of project coordination, project management, program support, or administrative project support experience in biotechnology, pharmaceuticals, or life sciences.
• Basic understanding of drug development, including preclinical development, CMC activities, and IND submissions.
• Strong organization, communication, interpersonal, and deadline-management skills.
• Proficiency with Microsoft Office and project management tools such as Microsoft Project or Smartsheet.
• Must be authorized to work in the United States; employment eligibility is verified through Form I-9 and E-Verify.

Nice to have

• Familiarity with Cell & Gene Therapy, biologics, or related therapeutic development.
• Experience working in cross-functional teams within a regulated environment.
• PMP or CAPM certification.

Culture & Benefits

• Medical, dental, and vision insurance.
• 401(k) retirement plan with a company match that fully vests on day one.
• Eight weeks of paid parental leave after three months of employment.
• Paid vacation, personal and sick time, floating holidays, and eleven company holidays.
• Additional flexible spending, health savings, disability, life insurance, commuter, family-care, and well-being benefits.
• Benefits are available exclusively to permanent full-time employees; contractors are not eligible.