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Regulatory Affairs Executive

VPDD Cadila Healthcare Ltd
Updated: 03/07/2025
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Employment Information

  • Work location: Ho Chi Minh

    Salary:

  • Industry: Pharmacy

    Deadline to apply:

  • Level: Experienced (Non - Manager)

Benefits

Chế độ bảo hiểm, Du Lịch, Phụ cấp, Chế độ thưởng, Chăm sóc sức khỏe, Tăng lương, Nghỉ phép năm

Job requirement

  • Study and review Product Dossiers to ensure full compliance with the regulations and requirements of the Drug Administration of Vietnam (DAV) and the Ministry of Health (MOH).

  • Submit Product Dossiers to DAV/MOH and respond promptly and accurately to queries or additional information requests from regulatory authorities.

  • Coordinate with the Regulatory Affairs team in India (Zydus India) to prepare, review, and finalize content for imported drug registration dossiers.

  • Keep up to date with regulatory legislation, circulars, decrees, and MOH guidelines related to drug registration and labeling.

  • Gather, evaluate, organize, and manage regulatory information in various formats to support dossier development and submission.

  • Track and monitor the entire registration process, including:

    • Supplementing documents as requested until marketing authorization is granted.

    • Updating or modifying dossiers following approval (registration number or SCB).

    • Preparing and submitting renewal applications ahead of expiration dates.

  • Define and approve requirements for product labeling, packaging, storage, and the content of information leaflets.

  • Prepare and submit weekly reports to the Chief Representative and other relevant internal departments.

  • Perform other tasks or special projects as assigned by the management.

Company Overview

VPDD Cadila Healthcare Ltd

Number of employees: 25-99

Representative office of Cadila Healthcare Ltd. in HCMC is one of India’s leading companies, placed among The Top 5 pharmaceutical companies in India with ~... View more

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