Mgr, Regulatory Affairs & QA

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Under limited supervision responsible for the implementation of regulatory strategies, obtain and maintain marketing authorizations for drug, biologic and medical device and communication of general regulatory requirements in support of licensing of Baxter’s products.

• Lead and manage QARA team by setting objectives and goals, conducting performance reviews and development plans, providing support, training, and mentoring.
• Accountable for alignment of regulatory and quality strategy to business strategy across all functional areas.
• Establish appropriate communication within QARA and other functions primarily at project level. Develop regulatory project plans, and align with global, regional and local marketing strategies.
• Lead RA team deliver and launch pipeline, accelerate approvals for key projects and deliver GEOx projects milestones on time.  Maintain market access for existing products life cycle management.
• Guide relationships with regulatory authorities to facilitate interactions on behalf of Baxter for critical issues
• Managing team to achieve all related registration activities including compile and submit the new product registrations, plant registrations, license extensions, variations according to agreed timeline, and ensure approvals in a timely manner;
• Monitor applicable regulatory requirements; assure compliance with Baxter and external standards;
• Actively participate in policy shaping activities by sitting in industry association;
• Support regulatory activities relating to specific portfolio of products/projects (product owner)
• Prepare, review, and approve labeling and SOP’s
• Review promotional material or SOP’s for compliance with local regulations
• Single point of contact for post market product quality related activities with TFDA
• Ensure applicable GQPs/quality processes are strictly followed in Baxter Taiwan.
• Ensure all local owned product quality related KPIs are fully met
• Communicates with manufacturing plants for significant quality issues or developments identified during quality activities and provides recommended process improvement to management
• Communication with TFDA/Testing Center for product quality management.
• Drive the global FA local implementation in Taiwan
• Develop and manage budget

Qualifications

• Sound basis of Regulatory knowledge and Quality regulation understanding
• Scientific Knowledge
• Ability to manage complex projects and timelines in a matrix team environment
• Written and Verbal communication and presentation skills
• Manage multiple projects and deadlines
• Ability to independently identify compliance risks and escalate when necessary
• Thorough knowledge of applicable procedures, specifications, regulations and standards.
• Strong people leadership and influencing skill
• Capability of providing local and global stakeholders the interpretation of local regulations
• Fluent in writing and speaking English

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.

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