JB-1602 - Senior Executive - Regulatory Affairs

Job Summary

Job Description Review analytical methods for APIs and finished pharmaceutical products.

Responsibilities

• 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 of experience in QC or analytical validation roles.
• Hands-on experience reviewing analytical method validation documentation.
• Should have good communication skills.
• Strong analytical data interpretation and technical documentation review skills.
• High technical ownership without laboratory or shop-floor operations.

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