Veeva RIM Specialist: Regulatory Submissions Expert

Scorpion Therapeutics; Summit (NJ); On-site; USD 95,000 - 135,000; Full time

Job summary

Scorpion Therapeutics is seeking a Veeva RIM Specialist to manage regulatory documents and ensure conformance with Health Authority requirements. You will support US and ex-US regulatory activities, maintain an inspection-ready system, and assist with submissions using Veeva RIM.

The role emphasizes hands-on document management, lifecycle tracking, and collaboration with Regulatory Affairs, IT, and clinical teams to translate business needs into technical solutions.

Qualifications

• Bachelor’s degree in life sciences/technical discipline with 5+ years regulatory operations experience in biotech/pharma or High School diploma with 9+ years.
• Hands-on experience with Veeva RIM and Veeva Vault.
• Global regulatory submissions and Health Authority correspondence familiarity (strongly preferred).

Responsibilities

• Create and maintain electronic project folders.
• Upload, track, and maintain life cycle of regulatory submissions (INDs, BLAs, CTAs) for US and ex-US regions in Veeva RIM.
• Maintain Veeva RIM by uploading submissions, Health Authority correspondence, etc.
• Track regulatory meetings, questions, information requests, and responses; ensure proper linking in Veeva RIM.
• Upload/manage Word and source documents in Veeva Vault for collaboration, version control, and updates.
• Capture and file regulatory documents received via email, secure links, or external portals in addition to gateway submissions.
• Assist with internal audits, Health Authority inspections, and regulatory inquiries related to RIM documentation.
• Organize and maintain working files, forms, sign-out sheets, and archives per SOPs and Health Authority requirements.
• Configure Vault objects, lifecycles, workflows, document types, and metadata.
• Provide technical/functional support for Veeva RIM user access.
• Assist with system validation, upgrades, and testing (GxP and regulatory standards).
• Partner with Regulatory Affairs, IT, and clinical teams to translate business requirements into technical solutions.
• Train Regulatory Documentation Specialists; provide post-training support.
• Serve as operational contact for Regulatory Affairs regarding Veeva RIM; provide day-to-day user support.
• Support upgrades/new software/removal of unused programs; perform ad-hoc cross-functional duties.

Skills

Regulatory operations

Veeva RIM

Veeva Vault

Documentation management

Project organization

Education

Bachelor’s degree in life sciences/technical discipline

High School diploma (with 9+ years experience)

Tools

Veeva RIM

Veeva Vault

Electronic Document Management Systems

Job description

Scorpion Therapeutics is seeking a Veeva RIM Specialist to manage regulatory documents and ensure conformance with Health Authority requirements. You will support US and ex-US regulatory activities, maintain an inspection-ready system, and assist with submissions using Veeva RIM.

The role emphasizes hands-on document management, lifecycle tracking, and collaboration with Regulatory Affairs, IT, and clinical teams to translate business needs into technical solutions.