Lead - Regulatory Information Management

Weekday AI (YC W21); Italia; Ibrido; EUR 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

A leading consulting firm is seeking a Lead - Regulatory Information Management professional with 8-12 years of experience. The role focuses on managing regulatory data and implementing Veeva RIM systems while ensuring compliance with global health authority requirements. The ideal candidate will leverage their expertise in Ennov and regulatory processes to optimize operations. This full-time position allows for contribution to global regulatory operations and mentoring of junior team members.

Competenze

• 8-12 years of experience in Regulatory Information Management or Regulatory Operations within life sciences.
• Strong hands-on experience with Veeva RIM modules.
• Strong expertise in Ennov and solid understanding of regulatory submission processes.

Mansioni

• Lead and support Veeva RIM implementations and operations.
• Act as a subject matter expert for Ennov.
• Manage global regulatory data for multiple regions.
• Drive data quality and governance in Veeva RIM and Ennov.
• Mentor junior team members on regulatory systems.

Conoscenze

Veeva RIM expertise

Ennov knowledge

Stakeholder management

Communication skills

Documentation skills

Regulatory submission processes

Strumenti

Veeva RIM

Ennov

Descrizione del lavoro

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