Manager, Regulatory Affairs

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

As a Manager, Regulatory Affairs
, you will develop and execute regulatory strategies that support business objectives throughout the product lifecycle. You will lead regulatory activities for a portfolio of products, ensuring compliance with global regulatory requirements while providing strategic guidance for product development, lifecycle management, and cross‑functional initiatives. This role serves as a key liaison between Baxter, regulatory authorities, and internal stakeholders to drive successful regulatory outcomes.

• Develop and execute regulatory strategies aligned with business objectives for new product development and lifecycle management activities.
• Lead regulatory activities for assigned product portfolios, ensuring timely submissions, approvals, and compliance commitments.
• Identify regulatory risks, assess potential impacts, and implement mitigation strategies to support project success.
• Monitor global regulatory requirements and ensure compliance with applicable regulations, standards, and Baxter procedures.
• Conduct regulatory gap assessments and implement process improvements to enhance compliance and operational efficiency.
• Develop, document, and defend regulatory positions and recommendations based on sound regulatory and scientific principles.
• Serve as the primary regulatory contact with health authorities and support regulatory communications and interactions.
• Partner with cross-functional teams to align regulatory strategies, timelines, and deliverables with business objectives.
• Provide strategic regulatory guidance throughout product development and lifecycle management activities.
• Review and contribute to regulatory‑related procedures and documentation to ensure alignment with evolving global requirements.
• Represent Baxter in industry associations, trade organizations, and external working groups as appropriate.
• Lead, coach, and develop regulatory team members while fostering a collaborative and high‑performing environment.

Minimum Requirements

• Bachelor's degree in a scientific discipline or equivalent.
• 5+ years of Regulatory Affairs experience or related experience within a regulated industry.
• Experience leading projects, cross‑functional initiatives, and/or people management responsibilities.
• Knowledge of global regulatory requirements, guidance documents, and compliance expectations.
• Strong understanding of product lifecycle management and regulatory submission processes.
• Demonstrated ability to assess regulatory risks and develop effective mitigation strategies.
• Strong communication, presentation, and stakeholder management skills.
• Ability to manage multiple priorities and deliver results in a fast‑paced environment.
• Experience collaborating effectively within cross‑functional and global teams.
• Experience working directly with global health authorities and regulatory agencies.
• Experience supporting complex product development programs and marketed product portfolios.
• Demonstrated success leading regulatory strategy for global submissions and approvals.
• Experience representing Regulatory Affairs in industry organizations, trade associations, or external working groups.
• Prior people management experience with responsibility for coaching and developing team members.