JD
¡¤ Performs required activities within the country that lead to activation of investigative sites in all phases of clinical trials;
¡¤ Prepare, review, and file, under regulation, IND/CTA to Regulatory Agencies (MFDS) with global submission strategy;
¡¤ Communicate with global RSMs and RAs for the documentation required and support needed;
¡¤ Responsible for providing expertise in ethics and regulatory submissions, and review and finalization of essential documents required for site activation;
¡¤ Act as main contact for Ethical and Regulatory submission-related activities;
¡¤ Direct contact with sites during the study start process;
¡¤ Ensure submissions comply with applicable regulations and guidance documents;
¡¤ Advise sponsors on changing regulations and compliance requirements;
¡¤ Bachelor's degree in the science field or equivalent combination of education and experience;
¡¤ At least one year of relevant working experience in CRO or Pharmaceutical Company
¡¤ Experience in preparing and submitting MFDS clinical trial applications
¡¤ Experience in negotiating with Regulatory Agencies;
¡¤ Excellent organization and communication skills;
¡¤ Knowledge of Microsoft¢ç Office;
¡¤ Knowledge of ICH, MFDS, IRB/IEC and other applicable regulations/guidelines;
¡¤ Hands-one experience preparing, reviewing, and submitting regulatory documentation to Ethics
¡¤ Committees and Regulatory Agencies;
¡¤ Fluency in English and local language
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