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PRMS Architect (Pharma Regulatory / RIMS / Product Registration)

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Ampstek
📍 Kakinada, India
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Location Kakinada
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Posted June 15, 2026
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Commute Local Area
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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 global rollout

Required Skills

• Str...

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📍 Location Details

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City
Kakinada
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Country
India
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Commute
Local Area

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