Job Description

• Review analytical
methods for APIs and finished pharmaceutical products.

• Review analytical
method validation protocols and validation study
reports.

• Review API and
finished product specifications, limits, and acceptance
criteria.

• Review stability
study data and shelf-life justifications in line with ICH
guidelines.

• Review DMF analytical
sections and critical API quality attributes for
compliance.

• Verify analytical
compliance for BE study sample testing and reporting
activities.

• Identify analytical
documentation gaps impacting regulatory acceptability.

• Support preparation
of analytical-related responses to regulatory authority
queries.

• Verify alignment of
analytical data with CTD Module 3 structure and
expectations.

• Maintain accuracy,
traceability, version control,



and integrity of analytical
records.

Requirements
• Bachelor’s or
Master’s degree in Pharmacy is mandatory.

• Minimum three years
experience in QC or analytical validation roles.

• Hands-on experience
reviewing analytical method validation documentation.

• Should have positive
communication skills.

• Solid analytical
data interpretation and technical documentation review
skills.

Benefits
• Remote working option
with defined review responsibilities.

• Flexible working
hours aligned to dossier and submission timelines.

• High technical
ownership without laboratory or shop-floor operations.

📌 Senior Executive - Regulatory Affairs (Dehradun)
🏢 Rhydburg
📍 Dehradun