Regulatory Affairs Manager

Vantive: A New Company Built on Our Legacy

Since last year, Baxter has been on a journey to separate our 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 sale of Vantive to funds managed by the Carlyle Group is subject to receipt of customary regulatory approvals and satisfaction of other closing conditions.

Essential Duties and Responsibilities:

• Develop and execute regulatory cluster strategy and plans aligned with business  for complex projects including new products and maintenance of licenses/ authorizations for existing marketed products.
• Provide technical and strategic input for regulatory decisions aligned with business strategy.
• Identify & prioritize key areas of risk and probability of occurrence as well as ensure implementation of mitigation plans and follow ups
• Monitor, evaluate, and interpret applicable cluster country regulatory requirements, assure compliance with Baxter and external standards
• Assess impact of new regulations with regional impact and provide feedback.
• Maintain appropriate communication within the RA function, with cluster Marketing, and with other functions primarily at the project team level
• Plan and manage complex projects and prioritize workload
• Ensure regulatory strategy and deliverables are aligned with project teams and business objectives.
• Develop and execute role-based regulatory plans aligned with business needs.
• Work with Country RA teams to align submission strategy and support dossier delivery.
• Represent the RA function on cluster assigned cross-functional project teams.

Education & Experience:

• Bachelor’s degree or country equivalent in a scientific discipline
• Master’s degree or PhD and advantage
• Minimum 8-year experience in drug or medical device RA or QA work including management of people.

• Strong regulatory knowledge on medical device regulatory laws in different countries (preferably SEA

• Technical knowledge and management skills

• Ability to manage complex projects and timelines in a matrix team environment

• Strong interpersonal, communication and presentation skills

• Strong negotiation skills

• Ability to lead and coach others

  Excellent organization skills

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.