Senior Regulatory Affairs Executive
6 days ago
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 eCTD 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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