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[담당업무] 1. Strategic Leadership: Formulate and drive global regulatory strategies for pre-clinical and clinical programs,
aligning with the company's broader objectives and ensuring regulatory compliance.
2. Documentation & Submission: Lead the preparation, coordination, and submission of comprehensive
regulatory documentation, ensuring accuracy and adherence to regulatory standards.
3. Cross-functional Collaboration: Act as the regulatory voice in cross-functional teams, integrating regulatory considerations into project plans, strategies, and decision-making processes.
4. Regulatory Agency Interaction: Build and maintain strong relationships with the FDA and other global regulatory authorities, facilitating open communication and prompt response to regulatory inquiries.
5. Regulatory Intelligence: Continuously monitor and analyze evolving regulatory guidelines, ensuring the
organization remains compliant and is informed of relevant changes.
6. Cross-Functional Leadership: Act as a mentor and guide for cross-functional teams, fostering a culture of
collaboration and ensuring alignment with regulatory objectives.
7. Risk Management: Proactively identify potential regulatory risks, develop mitigation strategies, and ensure the smooth progression of development programs.
8. Consultant Collaboration: Collaborate effectively with external Regulatory consultants, ensuring seamless
integration and alignment with the company's regulatory objectives.
9. Meeting Coordination: Organize and lead regulatory meetings, ensuring thorough preparation, including
the development of briefing documents and conduct of rehearsals.
10. Regulatory Guidance: Provide clear regulatory guidance to project teams, keeping them informed of
regulatory requirements, potential changes, and overall regulatory landscape
[근무부서 및 직급/직책]
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[자격요건] 경력: 경력 15년↑
학력: 대졸 이상
직무기술: 의료인허가
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