Lead the design and implementation of Product Registration / Regulatory Information Management systems (PRMS/RIMS) supporting global regulatory submissions and lifecycle management.
Key Responsibilities
Define solution architecture for regulatory systems aligned to global compliance (FDA, EMA, MHRA, ASEAN)
Design and manage product registration lifecycle (submission, approval, renewal, variation)
Integrate PRMS with:
ERP systems (QAD / SAP / Oracle)
Document systems (Veeva Vault / DMS)
Ensure compliance with:
GxP, 21 CFR Part 11, audit trails, validation processes
Drive data governance and master data strategy for regulatory content
Lead vendor evaluation, implementation, and global rollout
Required Skills
Robust experience in RIMS / PRMS / Veeva Vault RIM / similar platforms
Deep understanding of CTD, eCTD, regulatory submissions workflows
Knowledge of GxP, validation (CSV), data integrity
Integration experience across enterprise applications
Experience
10 years (with Pharma domain)
📌 PRMS Architect (India)
🏢 Infowaysolutions
📍 India
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