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Summary:

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.

Qualifications:

• Expert knowledge of drug regulations• Good communication and problem-solving skills
• Excellent time management and project management skills
• Ability to collaborate with cross-functions
• Pharmacists are preferred.

Education and/or Experience:

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations
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