Senior Regulatory Affairs Executive

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.

9109472707