Sr Mgr, Regulatory Affairs

Responsibilities

• 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

Requirements

• Bachelor's degree or country equivalent in a scientific discipline
• Master's and/or PhD will be preferred
• Minimum of 7-year experience in RA
• Expert 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
• Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
• #LI-RS1
• US Benefits at Baxter (except for Puerto Rico)

Benefits

Additional Information

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 Baxter A 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.

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