Sr. Executive- International Regulatory Affairs

To review, compile, verify, and coordinate technical documentation related to finished pharmaceutical products and Active Pharmaceutical Ingredient (API) Drug Master Files (DMFs) to support regulatory submissions and ensure compliance with applicable regulatory requirements.

Role & responsibilities

1. Review and verify technical documentation for finished pharmaceutical products and API DMFs.
2. Examine technical documents for completeness, accuracy, consistency, and compliance with applicable regulatory requirements.
3. Coordinate with Quality Assurance (QA), Quality Control (QC), Production, R&D, and other relevant departments to obtain and verify required documentation.
4. Review batch-related documents, batch release documentation, and other quality records, wherever applicable.
5. Support the preparation, compilation, review, and maintenance of regulatory dossiers and supporting technical documents.
6. Identify documentation gaps or discrepancies and coordinate with relevant departments for timely resolution.
7. Maintain proper records, document versions, and traceability of regulatory and technical documents.
8. Coordinate with internal teams and external stakeholders for documentation-related requirements.
9. Travel to Rusoma or Stanford, as required, for documentation review, collection, coordination, and related activities.
10. Ensure timely completion of assigned documentation activities and adherence to internal procedures and regulatory timelines.

Preferred candidate profile

• Good understanding of pharmaceutical technical documentation and API DMFs.
• Experience in reviewing finished product documentation.
• Knowledge of QA documentation, batch documentation,and batch release processes.
• Strong attention to detail and document-review skills.
• Good coordination, communication, and follow-up skills.
• Ability to identify documentation gaps and ensure timely closure.