[담당업무]

- Regulatory Strategy and Planning: Develop and implement regulatory strategies for the re-registration of pharmaceutical products with authorities. Coordinate with cross-functional teams to ensure alignment on regulatory timelines and deliverables.
- Documentation and Submission: Prepare and compile high-quality regulatory submission dossiers in accordance with regulatory requirements. Ensure all documentation is accurate, complete, and submitted within the required timelines.
- Compliance and Monitoring: Monitor regulatory changes and updates to ensure compliance with all relevant guidelines and regulations. Maintain up-to-date knowledge of Indian regulatory requirements and ensure that the company complies with all applicable laws and standards.
- Communication and Liaison: Act as the primary point of contact with authority, and other relevant regulatory authorities. Facilitate communication between internal departments and external stakeholders to ensure a smooth approval process.
- Project Management: Track and manage the progress of all re-registration activities. Provide regular updates to senior management and other stakeholders on the status of approvals.

[자격요건]

    - Bachelor’s degree in Pharmacy, Life Sciences, or a related field; advanced degree preferred
    - Minimum of 5-10 years of experience in regulatory affairs within the pharmaceutical industry
    - Proven track record of successful regulatory submissions and approvals
    - Strong understanding of country guidelines and regulatory requirements. Familiar with Drug Master file.
    - Excellent organizational, analytical, and project management skills
    - Strong communication skills, both written and verbal. Native in Korean and business level in English.