• Regulatory Strategy: Coordinate with GRA and BU to implement regulatory strategies for product development and commercialization.
• Document Preparation: Prepare and submit all necessary regulatory documents, such as New Drug Applications (NDA), Plant Master File (PMF), Drug Master File (DMF), Post-marketing activities (License Renewal, Variations) and other submissions to regulatory authorities.
• Compliance: Ensure ongoing compliance with global regulatory standards, including those set by the Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Taiwan FDA.
• Agency Liaison: Act as a primary point of contact with regulatory agencies, responding to their inquiries and providing requested information.
• Cross-Functional Collaboration: Work closely with R&D, QA, PV, manufacturing, BU and marketing teams to ensure regulatory considerations are integrated into all stages of product development.
• Product Labeling and Advertising: Assess and approve product labeling, packaging, and advertising materials to ensure compliance with regulations and accurate scientific claims.