(Sr) RA Specialist

About the role

This role is part of organization Taiwan regulatory affairs, involves drugs registration responsibility in Taiwan. Under limited supervision responsible for role-based activities (e.g.: the delivery of regulatory documents/deliverables/packages in support of Baxter ' s products/projects. Development/maintenance of Regulatory systems, trackers and databases. Evaluation and dissemination of new/changing regulations, guidance and standards.) Essential Duties and Responsibilities: - 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.