Manager, Regulatory Project Management (Biotechnology)

Location: Hybrid in Somerset, New Jersey, United States. Applicants must be authorized to work in the United States.

Base pay: $110,706–$145,303 per year, 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 NK cell-based therapies for serious diseases.

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.
• Monitor project progress, risks, delays, resource constraints, budgets, purchase orders, invoices, and resource utilization.
• Support IND submissions and other regulatory filing activities throughout the product development lifecycle.
• Facilitate communication with internal stakeholders, CROs, CDMOs, vendors, and external collaborators.
• Maintain project documentation and contribute to improvements in 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 experience in project coordination, project management, program support, or administrative project support in biotechnology, pharmaceuticals, or life sciences.
• Basic understanding of drug development, including preclinical development, CMC activities, and IND submissions.
• Strong organizational, communication, interpersonal, and prioritization 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 will be verified through Form I-9 and E-Verify.

Nice to have

• Experience with Cell & Gene Therapy, biologics, or related therapeutic development.
• Experience working in cross-functional teams within a regulated environment.
• PMP or CAPM certification.
• Master’s degree in a relevant scientific field.

Culture & Benefits

• Hybrid work environment in Somerset, New Jersey.
• Medical, dental, and vision insurance with a 401(k) plan and company match vesting fully on day one.
• Eight weeks of paid parental leave after three months of employment.
• Paid vacation, personal time, sick time, floating holidays, and eleven company holidays.
• Additional benefits include flexible spending and health savings accounts, disability coverage, commuter benefits, family planning resources, and well-being initiatives.
• Benefits are available exclusively to permanent full-time employees; contractors are not eligible.