Senior regulatory affairs executive

4 weeks ago

Ahmedabad, India White Force Group Full time

CTC - 8 Lpa Exp - 5+ years Your Key Responsibilities ● Dossier Preparation & Compilation: Lead and oversee the preparation, review, and submission of regulatory dossiers in CTD, ACTD, and e CTD formats for global markets, ensuring compliance with country-specific guidelines. ● Regulatory Strategy & Market Compliance: Develop and execute regulatory strategies for product approvals in the ROW, LATAM, SEA, Africa, and Pacific regions. ● Bioequivalence Studies & Compliance: Ensure compliance with bioequivalence study requirements for international submissions and coordinate with CROs for study approvals. ● Product Lifecycle Management: Manage regulatory aspects throughout the product lifecycle, including renewals, variations, and post-marketing compliance. ● Product Registration & Market Expansion: Handle product registration processes, liaising with regulatory authorities and ensuring smooth approvals in targeted markets. ● Technical File Review: Ensure accuracy and completeness of technical files for regulatory submissions. ● Regulatory Compliance & Audits: Monitor and ensure compliance with country-specific regulatory guidelines, including WHO-GMP, ICH, and other applicable standards. ● Regulatory Documentation & Reporting: Maintain up-to-date regulatory documentation and provide periodic reports to senior management. ● Stakeholder Management: Serve as the primary liaison between regulatory agencies, internal teams, and external partners to facilitate submissions and approvals. ● Process Improvement & Team Leadership: Implement process improvements, mentor junior regulatory staff, and drive efficiency in regulatory operations.

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