Sr. Executive, IRA (Regulatory Affairs)

La Renon Healthcare; Ahmedabad District; On-site; INR 500,000 - 750,000; Full time

Job summary

La Renon Healthcare, Ahmedabad, is seeking a detail-oriented Documentation Review Specialist to verify API DMFs and finished product documents. You will coordinate with QA, QC, Production, and R&D to compile regulatory dossiers and ensure compliance with timelines.

You will travel domestically within India to manufacturing facilities as required, maintain version control, and close documentation gaps through cross-functional collaboration.

Qualifications

• Review finished product documentation and API DMFs for completeness and regulatory compliance.
• Coordinate with QA, QC, Production, R&D to obtain and verify documentation.
• Maintain records, document versions, and traceability for regulatory documents.
• Identify gaps and drive timely resolution with cross-functional teams.

Responsibilities

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

Skills

Documentation review

Detail orientation

Coordination

Communication

Education

B.Pharm / M.Pharm / B.Sc / M.Sc

Job description

Job Description

La Renon has been offering innovative and world class pharmaceutical products since 2007 with a commitment towards healthier lives globally. Valued at more than half a billion USD in 2021 and ranked amongst top 25 pharma companies of India in a very short span since inception. La Renon Healthcare has been known to be one of the fastest growing pharmaceutical companies in the Indian market. Our rapid growth has attracted investment from Sequoia in 2015, A91 in 2021 and Chrys Capital in 2024. We consistently strive to create innovative solutions towards management of lifestyle and chronic diseases.

Ahmedabad

Education

B.Pharm. / M.Pharm. / B.Sc. / M.Sc.

Desired Candidate Profile

• 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.

Desired Keyskills

• 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.
• Willingness to travel and stay for one week at manufacturing facilities located in India as required for official documentation-related assignments.