PRMS Architect (Pharma Regulatory / RIMS / Product Registration)

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...