Sr Mgr, Regulatory Affairs

Job description

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. 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 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 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 for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview. 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) This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Know Your Rights: Workplace Discrimination is Illegal 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 .