Job Description
Job Role : PRMS Architect (Pharma Regulatory / RIMS / Product Registration)
Location : Bangalore/Pune/Hyderabad/NCR region
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:
o ERP systems (QAD / SAP / Oracle)
o Document systems (Veeva Vault / DMS)
• Ensure compliance with:
o GxP, 21 CFR Part 11, audit trails, validation processes
• Drive data governance and master data strategy for regulatory content
• Lead vendor evaluation, implementation, and...