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1. Regulatory submissions and approvals of products:
· Maintain up-to-date information on data requirements for product approvals including both new and changes in regulatory requirements
· In accordance to aligned plan with Singapore Dossier Centre, make submissions for all import approvals in timely manner:
- Ensure submission data package in alignment with regulatory requirements
- Prepare Korean-translated version of dossiers using data package supplied by Singapore Dossier Centre
- Complete submissions in timely manner
· Manage preparation of response documents to questions from regulators during regulatory reviews
- Lead collaboration with Singapore Dossier Centre & US regulatory affairs, accurately communicate regulators’ questions and expectations, and facilitate development of appropriate responses
- Prepare Korean-translated version of response documents and submit in timely manner
· Monitor other industry product submission and approval status, and alert any potential issues or opportunities to management team (Korea lead, Singapore Dossier Center, Intl (Asia-Pacific) RA, and US RA)
2. Assist execution of communication (scientific outreach) programs (i.e., scientific white paper submission, presentations to technical review committee, workshop, etc.) to key scientists and regulators, and create wining environments for the acceptance of company safety assessment strategy and regulatory data package
3. Secure product approval status:
· Through close monitoring, communicate with management team regulatory process and data requirements of renewals of product approvals
· Make submissions of data package for product approval renewals in timely manner
· Monitor issues (local research activities, scientific workshops, published papers in scientific journals, newspapers, etc.) which have potential impacts or opportunities on our product approval status, analyze potential impacts, and alert management team in timely manner
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