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.

approvals in the ROW, LATAM, SEA, Africa, and Pacific regions.

international submissions and coordinate with CROs for study approvals.

renewals, variations, and post-marketing compliance.

regulatory authorities and ensuring smooth approvals in targeted markets.

guidelines, including WHO-GMP, ICH, and other applicable standards.

periodic reports to senior management.

and external partners to facilitate submissions and approvals.

staff, and drive efficiency in regulatory operations.

9109472707

Skills Required

dossier preparation , regulatory strategy, Process Improvement, Product Lifecycle Management, Stakeholder Management