International Regulatory Affairs Head

2 weeks ago

Ahmedabad, India Opes Healthcare Full time

Role & responsibilities

1.Prepare monthly regulatory MIS reports and present status updates, key metrics, and strategic insights to senior management.

  1. Manage relationships with external regulatory consultants, in-country partners, submission vendors, and the external regulatory team to ensure timely regulatory filings and ongoing compliance.

  2. Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap analysis, and submission readiness.

  3. Liaise with regulatory authorities including (EU, CIS, LATAM, ROW, Asia) and others.

5.Develop and implement regulatory strategies across international markets (EU, CIS, LATAM, ROW, Asia, Middle East, and Georgia) to ensure timely submissions and approvals for product registrations and lifecycle maintenance.

  1. Lead the preparation, review, and submission of CTD/eCTD/ACTD dossiers for multiple dosage forms including solid orals, injectables, topicals, and liquids for pharmaceutical and nutraceutical products, as per country-specific guidelines.

7.Manage lifecycle regulatory activities such as renewals, variations, line extensions, and prompt responses to health authority queries across global jurisdictions.

8.Maintain up-to-date knowledge of global regulatory and provide strategic recommendations based on updated guidelines and country-specific requirements.

9.Ensure regulatory compliance for labeling, artworks, inserts, and packaging as per regional regulations and internal quality standards.

10 .Support and participate in regulatory audits and inspections by ensuring the availability of complete and updated documentation and responses.

11.Lead and train junior regulatory staff, encourage cross-market knowledge transfer, and ensure consistent alignment with global regulatory processes and corporate objectives.

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