Regulatory Systems Manager
Ardelyx, Inc.
June 25, 2026
Remote friendly (Newark, CA)
United States
IT
Position Summary
The Regulatory Systems Manager is responsible for the administration, optimization, and day-to-day management of regulatory systems supporting global regulatory operations, ensuring regulatory information and documentation are maintained accurately and efficiently across systems used for submissions, health authority interactions, and product lifecycle management.
Responsibilities
- Serve as primary business owner and administrator for regulatory systems (e.g., regulatory information management, document management, submission publishing tools).
- Manage system configuration, user access/permissions, workflows, and data governance for accurate, compliant records.
- Oversee upgrades/releases, validation activities, and change control; maintain regulatory product/submission data and health authority correspondence.
- Develop and maintain SOPs, system documentation, and training materials.
- Support preparation and management of global regulatory submissions by aligning systems/document structures to submission requirements.
- Partner with Regulatory Affairs to track commitments, submissions, approvals, and lifecycle activities.
- Ensure global regulatory documentation is archived and maintained per company and regulatory requirements.
- Train and support regulatory teams using Veeva RIM (Registrations, Submissions, or Archive).
- Act as point of contact for system questions, troubleshooting, process guidance, and vendor coordination.
- Represent Regulatory Affairs in systems improvement projects with IT/external vendors; support testing, validation, and UAT.
- Ensure regulatory systems operate in compliance with applicable regulatory requirements and internal policies.
Qualifications
- Bachelor’s degree in regulatory affairs, information systems, or related field; 5+ years in regulatory operations/systems (or equivalent life sciences/pharma/biotech experience).
- Experience administering/supporting regulatory systems such as Veeva Vault RIM (Registrations, regulatory data management) or submission publishing tools.
- Experience supporting global regulatory submissions and product registration tracking.
- Strong understanding of regulatory operations and regulatory document lifecycle.
- Experience in GxP regulated environments.
- Strong attention to detail; data integrity and compliance focus.
- Excellent organizational, communication, and cross-functional collaboration skills.
- System implementation/configuration/upgrades experience preferred.
- Certification/training in Veeva Vault platform.
The Regulatory Systems Manager is responsible for the administration, optimization, and day-to-day management of regulatory systems supporting global regulatory operations, ensuring regulatory information and documentation are maintained accurately and efficiently across systems used for submissions, health authority interactions, and product lifecycle management.
Responsibilities
- Serve as primary business owner and administrator for regulatory systems (e.g., regulatory information management, document management, submission publishing tools).
- Manage system configuration, user access/permissions, workflows, and data governance for accurate, compliant records.
- Oversee upgrades/releases, validation activities, and change control; maintain regulatory product/submission data and health authority correspondence.
- Develop and maintain SOPs, system documentation, and training materials.
- Support preparation and management of global regulatory submissions by aligning systems/document structures to submission requirements.
- Partner with Regulatory Affairs to track commitments, submissions, approvals, and lifecycle activities.
- Ensure global regulatory documentation is archived and maintained per company and regulatory requirements.
- Train and support regulatory teams using Veeva RIM (Registrations, Submissions, or Archive).
- Act as point of contact for system questions, troubleshooting, process guidance, and vendor coordination.
- Represent Regulatory Affairs in systems improvement projects with IT/external vendors; support testing, validation, and UAT.
- Ensure regulatory systems operate in compliance with applicable regulatory requirements and internal policies.
Qualifications
- Bachelor’s degree in regulatory affairs, information systems, or related field; 5+ years in regulatory operations/systems (or equivalent life sciences/pharma/biotech experience).
- Experience administering/supporting regulatory systems such as Veeva Vault RIM (Registrations, regulatory data management) or submission publishing tools.
- Experience supporting global regulatory submissions and product registration tracking.
- Strong understanding of regulatory operations and regulatory document lifecycle.
- Experience in GxP regulated environments.
- Strong attention to detail; data integrity and compliance focus.
- Excellent organizational, communication, and cross-functional collaboration skills.
- System implementation/configuration/upgrades experience preferred.
- Certification/training in Veeva Vault platform.