Regulatory Documentation Specialist III (Biotechnology)

Location: On-site in Summit, New Jersey, Monday through Friday, during standard business hours.

Salary: $50.48–$55.53 per hour, plus eligibility for a discretionary bonus and equity award.

Company

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

What you will do

• Create and maintain electronic project folders, working files, templates, document shells, forms, signout sheets, and archives.
• Advise internal departments on preparing and submitting regulatory documentation.
• Format, compile, and quality-check regulatory documents, including bookmarks, hyperlinks, document properties, and style-guide compliance.
• Create submissions in submission software, publish documents, manage XML backbones in docuBridge, and complete links to related documents and datasets.
• Submit documentation to Health Authorities while ensuring compliance with SOPs and regulatory requirements.
• Assist with training specialists and collaborate on regulatory documentation software upgrades and changes.

Requirements

• Bachelor’s degree in life sciences or a technical discipline with 5+ years of regulatory operations experience in biotechnology or pharmaceuticals; alternatively, a high school diploma with 9+ years of relevant experience.
• Expert knowledge of Health Authority procedures and guidance for document management and electronic submissions.
• Expert knowledge of Electronic Document Management Systems and strong knowledge of Veeva Vault, especially Veeva RIM.
• Ability to meet 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, New Jersey, Monday through Friday.

Culture & Benefits

• Collaborative work across different areas of the company and project teams.
• Professional development opportunities in a growing biotechnology company.
• Medical, dental, and vision plan options, plus health and financial wellness programs.
• 401(k) retirement plan with company match, flexible spending accounts, life and disability coverage, and an employer assistance program.
• Paid time off, holidays, health pay, personal days, cultural days, and additional voluntary benefits and discounts.