Veeva RIM Specialist (Biotechnology)

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

Hourly base pay: $50.48–$55.53 per hour, depending on qualifications, experience, and geographic location. The role is also eligible 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 and regulatory archives.
• Upload, track, and maintain the lifecycle of regulatory submissions, including INDs, BLAs, and CTAs, for US and ex-US regions in Veeva RIM.
• Capture and organize Health Authority correspondence, meetings, questions, information requests, responses, source documents, and gateway submissions.
• Configure Vault objects, lifecycles, workflows, document types, and metadata to support regulatory business processes.
• Provide day-to-day technical and functional support for Veeva RIM users and assist with training Regulatory Documentation Specialists.
• Support audits, inspections, system validation, upgrades, testing, and cross-functional technical solutions with Regulatory Affairs, IT, and clinical teams.

Requirements

• Bachelor’s degree in life sciences or a technical discipline plus 5+ years of regulatory operations experience in biotechnology or pharmaceuticals, or a high school diploma plus 9+ years of experience.
• Hands-on experience with Veeva RIM and Veeva Vault.
• Expert knowledge of Health Authority procedures, electronic submissions, and document management.
• Strong knowledge of electronic document management systems, Veeva Vault, and Veeva RIM.
• Strong organizational, written and oral communication, deadline-management, and attention-to-detail skills.
• Ability to work on site in Summit, NJ and use computer systems for extended periods.

Nice to have

• Familiarity with global regulatory submissions and Health Authority correspondence.

Culture & Benefits

• Collaborative environment with cross-functional work across Regulatory Affairs, IT, clinical, and project teams.
• Professional development opportunities in a growing biopharmaceutical company.
• Medical, dental, and vision plan options, along with health and financial wellness programs.
• 401(k) retirement plan with company match, flexible spending accounts, disability coverage, and life insurance options.
• Paid time off, holidays, health pay, personal days, and other employee assistance and discount programs.