Sr Mgr, 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.

Your role at BaxterA Senior Manager of Global Regulatory Affairs leads the development and execution of regulatory strategies to support product approvals, lifecycle management, and compliance across international markets, with deep expertise in US FDA requirements. This role coordinates cross‑functional teams to prepare, review, and submit high‑quality regulatory filings, ensuring alignment with evolving global and US regulations. They serve as a strategic advisor to leadership, providing risk‑based guidance and driving regulatory excellence to enable timely market access and sustained product compliance.

What you'll be doing

Serves as the Global Regulatory Lead for Baxter’s hemostat and sealant product(s) registered as biologic/combination 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 all applicable regulatory requirements, assure compliance with Baxter and external standards

Assess impact of new regulations and provide feedback

Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks

Act as primary contact for meetings with regulatory authorities including planning and leadership

Maintain appropriate communication within the RA function, with Global Marketing, and with other functions primarily at the project team level

Plan and manage complex projects and prioritize workload

Initiate, manage and maintain operational activities in support of new and existing marketing authorizations

Set team, group, or service objectives to assure they align with the regulatory strategy

Represent Baxter interests in industry and working groups

Mentor junior colleagues on US regulatory requirements and submission strategies

What you'll bring

Bachelor’s degree or country equivalent in a scientific discipline

Master’s and/or PhD will be preferred

Minimum of 7-year experience in RAExpert Regulatory knowledge

Sound basis of Scientific (Training/ Communications) knowledge

Management skills

Ability to oversee multiple projects in a matrix team environment

Excellent oral and written communication and presentation skills

Demonstrated excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities

Technical and management skills

Ability to lead, coach, and motivate others

Ability to accomplish results through others

Ability to work effectively in multinational/multicultural environment

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $152,000 - $209,000 annually. The estimated range is meant to reflect an anticipated salary range…