1. Coordinates, reviews, and may prepare reports for ANDA, Orphan Drugs, Specific Medicinal Products' Manufacturing as a Special Case, and 505(b)(2) to the TFDA, including the PAS.
2. Assumes principle responsibility for the day-to-day regulatory business and interfaces with government and regulatory agencies to achieve the overall Taiwan business strategy/goal.
3. Can develop a regulatory strategic plan and work towards cross-functional teams to achieve the new product approval and successful launch in a timely fashion.
4. Renders commercial support to various departments at the affiliate level.
5. Ensure timely completion of assigned tasks from the MRA Director, including routine governance affairs of the company.