Sr. Executive- International Regulatory Affairs

La Renon Healthcare; Ahmedabad District; On-site; INR 700,000 - 1,000,000; Full time

Job summary

La Renon Healthcare is seeking a documentation reviewer to support regulatory submissions. You will review finished product and API DMFs, ensure completeness and regulatory compliance, and coordinate with QA, QC, Production and R&D to assemble required documents.

You will also review batch-related records, support dossier preparation, address documentation gaps, and maintain traceability of records. Willingness to travel to Rusoma or Stanford is required.

Qualifications

• Must understand pharmaceutical technical documentation and API DMFs.
• Experience 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.

Responsibilities

• Review and verify documentation for finished products and API DMFs.
• Examine documents for completeness, accuracy, and regulatory compliance.
• Coordinate with QA, QC, Production, R&D and other departments to obtain and verify docs.
• Review batch-related documents and release records where applicable.
• Support regulatory dossiers and related technical documents.
• Identify gaps and coordinate timely resolutions with relevant teams.
• Maintain traceability and proper records of documents.
• Coordinate with internal and external stakeholders for documentation needs.
• Travel to Rusoma or Stanford for documentation activities as required.
• Ensure timely completion of documentation tasks per procedures and timelines.

Skills

DMF review

Documentation review

Finished product docs

QA documentation

Batch release knowledge

Attention to detail

Coordination

Communication

Gap analysis

Job description

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.