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Senior Regulatory Affairs Executive

Senior Regulatory Affairs Executive

White Force GroupIndia
4 days ago
Job description

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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