JB-1602 - Senior Executive - Regulatory Affairs

Rhydburg Pharmaceuticals; Dehradun; Vor Ort; INR 550.000 - 750.000; Vollzeit

Zusammenfassung

Rhydburg Pharmaceuticals is seeking an experienced reviewer to assess analytical methods for APIs and finished products, ensure validation documentation quality, and support regulatory submissions. The role emphasizes data integrity and strict adherence to ICH guidelines.

You will verify specifications, study reports, and stability data, while maintaining traceability and version control across all analytical records. Strong communication and ownership are essential in a non-lab setting.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Analytical data interpretation

Technical documentation review

Communication skills

Quality control

Ausbildung

Bachelor's or Master's degree in Pharmacy

Jobbeschreibung

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.