Lead - Regulatory Information Management

Lead - Regulatory Information Management

1 day ago Be among the first 25 applicants

This role is for one of the Weekday's clients. Minimum experience: 8 years. Location: Europe. Job type: full-time.

We are seeking an experienced Veeva Regulatory Information Management (RIM) professional with strong expertise in Ennov to lead and support global regulatory operations and system implementations. The ideal candidate will play a critical role in managing end-to-end regulatory information, ensuring compliance with global health authority requirements, and driving digital transformation initiatives across regulatory systems.

This role requires a deep understanding of regulatory processes, hands-on experience with Veeva RIM modules, strong Ennov knowledge, and the ability to work cross-functionally with Regulatory Affairs, IT, Quality, and external partners.

Key Responsibilities

• 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.

Required Skills & Qualifications

• 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.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Other

Industries

IT Services and IT Consulting