Senior Regulatory Project Manager -- THADC5911040

Responsibilities

• Project Delivery: Lead end-to-end implementation of RIM modules (Registrations, Submissions, Dossier Management, and IDMP).
• Stakeholder Management: Partner with Regulatory Operations, Quality Assurance, and R&D leaders to define business needs.
• Compliance & Validation: Oversee GxP computer system validation (CSV) and data integrity protocols.
• Resource Control: Manage project scope, vendor relationships and resource allocation.
• Risk Management: Track project milestones, spot technical bottlenecks, and create risk mitigation plans.

Qualifications

• Education: Bachelor’s degree in Computer Science, Life Sciences, or a related field.
• Experience: 8+ years in IT project management with at least 5 years specifically in pharma, biotech, or medical device regulatory IT domains.

Skills

• Domain Expertise: Deep knowledge of regulatory submission processes and health authority standards (FDA, EMA, PMDA).
• Technical Acumen: Experience with RIM platforms (like Veeva Vault RIM, Ennov, or OpenText).
• Methodology: Certified in PMP, Agile, or Scrum frameworks.
• Change Management: Proven ability to drive user adoption across global life sciences teams.