Regulatory Documentation Specialist II (Biotechnology)

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

Salary: $45.66–$50.23 per hour, plus eligibility for a discretionary bonus and equity award.

Company

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

What you will do

• Create and maintain electronic project folders, working files, document shells, forms, sign-out sheets, and archives.
• Format reports, assessments, regulatory submissions, letters, and other documents according to style guides.
• Format and compile documents according to Regulatory Agency requirements.
• Publish documents with internal bookmarks and hyperlinks, insert content into XML backbones using docuBridge, and complete external hyperlinks to documents and datasets.
• Support eCTD module coordination and ensure document management follows SOPs and Health Authority requirements.
• Train Regulatory Documentation Specialists and provide ongoing support with SOP-related questions.

Requirements

• Bachelor’s degree in life sciences or a technical discipline and 2+ years of regulatory operations experience in biotechnology or pharmaceuticals; alternatively, a high school diploma and 6+ years of relevant experience.
• Working knowledge of Health Authority procedures and guidance for document management and electronic submissions.
• Working knowledge of Electronic Document Management Systems and Veeva Vault, especially Veeva RIM.
• Ability to work to firm deadlines and adapt to changing requirements and priorities.
• Strong organization, written and oral communication, and attention to detail.
• Ability to work on-site in Summit, NJ, Monday through Friday.

Culture & Benefits

• Collaborative environment with opportunities to work across different areas of the company.
• Professional development opportunities in a growing biopharmaceutical company.
• Medical, dental, and vision plan options, plus health and financial wellness programs.
• 401(k) retirement plan with company match and flexible spending accounts.
• Paid holidays, vacation, health pay, personal days, and cultural days according to employee classification.
• Life and disability insurance, employee assistance, legal services, identity theft protection, and other voluntary benefits.