Weekday is hiring a Lead - Regulatory Information Management to lead and support global regulatory operations and system implementations. You will manage end-to-end regulatory information, ensure compliance with global health authority requirements, and drive digital transformation initiatives across regulatory systems.
What You'll Do
- Lead and support Veeva RIM implementations, enhancements, and ongoing operations, including modules such as RIM Submissions, RIM Registrations, RIM Publishing, and RIM Archive.
- Act as a subject matter expert for Ennov, supporting regulatory document management, publishing, submissions, and lifecycle management activities.
- Manage global regulatory data including product registrations, submissions, variations, renewals, and commitments across multiple regions (US, EU, APAC, LATAM).
- Collaborate with Regulatory Affairs teams to define business requirements, translate them into system configurations, and ensure alignment with regulatory processes.
- Drive data quality, governance, and compliance within Veeva RIM and Ennov systems.
- Support system integrations between Veeva RIM, Ennov, and other enterprise systems (e.g., ERP, Quality, Clinical systems).
- Provide leadership in process optimization and standardization, leveraging best practices in regulatory information management.
- Lead or support user acceptance testing (UAT), validation activities, SOP creation, and end-user training.
- Ensure systems and processes comply with global regulatory standards and guidelines (FDA, EMA, MHRA, PMDA, etc.).
- Act as a key point of contact for vendors, system partners, and internal stakeholders.
- Mentor junior team members and provide guidance on regulatory systems and tools.
What We're Looking For
- 8–12 years of experience in Regulatory Information Management or Regulatory Operations within life sciences (pharma, biotech, medical devices).
- Strong hands-on experience with Veeva RIM (Submissions, Registrations, Publishing, Archive).
- Strong expertise in Ennov (Publishing, Submissions, Regulatory DMS, or related modules).
- Solid understanding of regulatory submission processes and health authority requirements.
- Experience working in GxP-compliant environments with system validation exposure.
- Excellent stakeholder management, communication, and documentation skills.
- Ability to work in global, cross-functional, and matrixed environments.
Nice to Have
- Experience with Veeva Vault platform configurations.
- Exposure to data migration, system upgrades, or large-scale RIM transformations.
- Prior experience in lead or solution architect roles.
Technical Stack
- Veeva RIM (Submissions, Registrations, Publishing, Archive)
- Ennov (Publishing, Submissions, Regulatory DMS)
Team & Environment
Work cross-functionally with Regulatory Affairs, IT, Quality, and external partners.
Work Mode
This role is local-country based in Europe.
Weekday is an equal opportunity employer.
