Weekday (YC W21)

Lead – Regulatory Information Management

Weekday (YC W21)

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇩🇪 Germany

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Job Level

Senior

Tech Stack

ERP

About the role

  • 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.

Requirements

  • 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.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
Veeva RIMEnnovregulatory document managementsystem validationdata qualitycomplianceprocess optimizationuser acceptance testingSOP creationlifecycle management
Soft skills
stakeholder managementcommunicationdocumentationleadershipmentoringcollaborationguidanceorganizational skillsproblem-solvingadaptability