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, QA or R&D; or analytical validation roles.

• Hands-on experience reviewing analytical method validation documentation.

• Sound working knowledge of ICH guidelines and pharmacopeial standards.

• Strong analytical data interpretation and technical documentation review skills.

Perks

• 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