Lead - Regulatory Information Management
Pubblicato il 01-08-2026 - Weekday AI in Italia
This role is for one of the Weekday's clients
Min Experience: 8 years
Location: Europe
JobType: 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
.