PRMS Architect

Title: PRMS Architect
Location: United States (Remote)
Duration: 6 months (possibility of an extension)
Implementation Partner: Infosys
End Client: To be disclosed (Pharma)

JD:

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

Strong 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)