Job Description
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 good 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.

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 good communication skills. Strong analytical data interpretation and technical documentation review skills.

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