Mgr, Regulatory Affairs

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.

Report to Head of QARA

Registration and maintenance of Medical Devices and Drug

• Develop and execute regulatory plans aligned with business strategy for complex projects including new products and maintenance of regulatory files for existing marketed products
• Identify & prioritize key areas of risk, and develop & implement appropriate mitigation plans
• Establish appropriate communication within RA, with global Marketing, and with other functions at project level and favor proactive communication
• Ensure Registration strategy and deliverables are aligned with project teams and business objectives
• Lead regulatory activities related to their portfolio of products
• Prepare, review, and approve labeling, J-CTD based on global dossier and in cooperation with PV/MDS and confirm sufficiency of total submission dossier package for approval
• Represent or lead the RA function on assigned cross-functional project teams
• May participate external advocacy activity and contribute internal environment improvement
• May provide direct supervision of individuals
• Monitor applicable regulatory documentation and propose solutions. Identify areas for improvement
• Develop and document sound regulatory decisions and justification

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.