Veeva RIM expert

Job Title: Veeva RIM expertLocation: Remote (USA)Job Summary:We are seeking a highly experienced Veeva RIM Expert with a proven track record of leading complex global regulatory initiatives, data readiness, system implementation, and post-implementation support within the life sciences industry. The ideal candidate will bring deep domain expertise in Regulatory Information Management (RIM), Veeva Vault, CMC compliance, change management, and global regulatory operations across mergers, acquisitions, and large-scale transformation programs.Key Responsibilities:Strategic and Program Leadership:

• Serve as the lead SME and program manager for large-scale Veeva Vault RIM implementations, including requirements gathering, business process analysis, configuration oversight, UAT, and hypercare support.
• Drive data enrichment, data migration, and IDMP-readiness programs, ensuring alignment with evolving global regulatory requirements and business needs.
• Lead Regulatory Transformation Initiatives such as legal entity rationalization, post-merger integration, and process simplification initiatives.

Regulatory Information Management:

• Manage end-to-end RIM system implementation lifecycle—from discovery and process mapping to post-go-live support.
• Oversee business-as-usual RIM data maintenance, ensuring data integrity, compliance, and usability across multiple regulatory functions.
• Collaborate with global regulatory affairs, IT, and compliance teams to harmonize regulatory data standards and establish effective governance models.

Change Management & Communication:

• Lead change management activities, including scenario creation, stakeholder engagement, training design, and execution of communication plans.
• Act as the communications SPOC for regulatory transformation programs, including developing hypercare dashboards and stakeholder reporting.

Regulatory CMC and Operations:

• Provide subject matter expertise in CMC regulatory compliance, authoring and reviewing Module 3 content, comparative analysis, and dossier updates.
• Lead cross-functional global teams in submission readiness, including document collation, review, and quality assurance.

Regulatory Process & Business Analysis:

• Analyze current and future-state business processes and workflows to support digital transformation in regulatory operations.
• Develop and maintain procedural documentation (SOPs, BPs, templates), and act as a technical writer for internal process harmonization.

Required Skills and Qualifications:

• Bachelor's or Master's degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field.
• 9–12+ years of relevant experience in Regulatory Affairs/Regulatory Operations, with at least 4–6+ years hands-on experience in Veeva Vault RIM (including Registrations, Submissions, Archive, Commitments).
• Deep knowledge of regulatory data standards, GxP compliance, IDMP/xEVMPD, and Module 3 CMC documentation.
• Demonstrated experience in leading global regulatory projects across multiple markets (including LATAM, EMEA, APAC, NA).
• Strong working knowledge of Veeva Vault, Liquent Insight Manager, Global Submission Viewer, and document/dossier management systems.
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Project), and technical documentation.
• Experience with system validation (CSV), UAT execution, and post-implementation hypercare support.
• Excellent interpersonal and communication skills, with ability to manage stakeholders at all levels.

Preferred Qualifications:

• Lean Six Sigma Green Belt Certification (preferred).
• Experience in supporting M&A, divestiture, and legal entity rationalization programs.
• Familiarity with global regulatory submission requirements (eCTD, NeeS, etc.) and procedure types (CP, MRP, DCP, NP).
• Completion of leadership training programs (e.g., WAVE or equivalent) is a plus.

Job Types: Full-time, Contract

Pay: $ $65.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Experience:

• Regulatory Affairs/Regulatory: 8 years (Preferred)
• CMC documentation: 5 years (Preferred)
• Veeva RIM: 5 years (Preferred)

Work Location: Remote