PRMS Architect (Pharma Regulatory / RIMS / Product Registration)

Role Summary

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