Lead, Regulatory Affairs

Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

Role Summary

• Responsible and accountable for all local operational aspects of regulatory submissions providing planning and technical support for Baxter’s products.
• Instrumental in the design and definition of the Regulatory strategy for the products.
• Manage regulatory activities relating to specific portfolio of products/projects. 
• Represent Baxter RA in external engagements
• Role includes management of RA team members as well as ensuring Baxter interests are considered in government, industry and working groups

Area of Responsibilities

• Lead RA team for new product registrations, license extensions, variations, renewals per agreed timeline, and ensure approvals in a timely manner for entire portfolio – inclusive of drugs and devices.
• Develop and execute regulatory strategy and plans aligned with business for complex products including new products and maintenance of licenses thereby ensuring regulatory compliance for distributed products e.g., in terms of licenses, permits, GMP clearances, labeling, promotional materials, archiving etc.
• Identify and prioritize key areas of risk and develop & implement appropriate mitigation plans
• Perform gap analysis on regulatory documentation and propose solutions. Identify areas for improvement.
• Develop and document sound regulatory decisions and justifications.
• Report progress of key regulatory activities to the leadership team.
• Monitor applicable regulatory requirements; assure compliance with the company’s and external standards.
• Represent or lead the RA function on assigned cross-functional project teams
• Represent company interests in government, industry and working groups
• Provide direct supervision of individuals
• Establish communication and good working relationships within RA, other functions and the health authorities.
• Manage projects as determined.
• May compile regulatory documents for submission per local requirements.
• May prepare, review, and approve labeling, SOPs and AdProm materials for compliance with local regulations

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.