Manager, Regulatory Affairs

Zvh; Town of Deerfield (WI); Hybrid; USD 120,000 - 165,000; Full time

Benefits offered by this job

Sign-on bonus

Flexible workplace policy

Competitive benefits

Job summary

Baxter is seeking a Manager, Regulatory Affairs in the United States to develop and execute regulatory strategies across product lifecycles. You will lead cross-functional teams, ensure submissions and approvals, and mentor regulatory staff in a fast-paced environment.

The role requires extensive experience with global regulatory requirements, strong communication, and the ability to navigate complex product development programs. Flexible workplace policy with some onsite requirements is offered.

Qualifications

• Bachelor's degree in a scientific field or equivalent.
• 5+ years of Regulatory Affairs or related experience in a regulated industry.
• Experience leading projects, cross-functional initiatives and teams.

Responsibilities

• Develop and execute regulatory strategies aligned with business objectives for new products and lifecycle management.
• Lead regulatory activities for assigned product portfolios with timely submissions and approvals.
• Identify regulatory risks, assess impacts, and implement mitigation strategies.
• Monitor global regulatory requirements and ensure compliance with regulations and Baxter procedures.
• Conduct regulatory gap assessments and implement process improvements for compliance.
• Develop, document, and defend regulatory positions based on regulatory science.
• Serve as primary regulatory contact with health authorities and internal stakeholders.
• Partner with cross-functional teams to align strategies, timelines, and deliverables.
• Provide strategic regulatory guidance throughout development and lifecycle management.
• Review and contribute to procedures to align with evolving global requirements.
• Represent Baxter in industry associations and external working groups.
• Lead, coach, and develop regulatory team members in a high-performing environment.

Skills

Regulatory strategy

Cross-functional leadership

Global regulatory

Stakeholder management

Lifecycle management

Risk assessment

Regulatory submissions

Communication skills

Project leadership

Team coaching

Education

Bachelor's degree in a scientific discipline

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 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.

What you’ll be doing

• 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.

What you’ll bring

• 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 on industry organizations, trade associations, or external working groups.
• Prior people management experience with responsibility for coaching and developing team members.
• Experience working in multinational and multicultural business environments.

$5,000 sign‑on bonus offered for this role. The $5,000 sign‑on bonus will be paid to external applicants successfully hired after completion of your first 30 days at Baxter. 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 $120,000 - $165,000 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.

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in‑person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change.

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.

US Benefits at Baxter (except for Puerto Rico)

• 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.

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

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally.

No matter your role at Baxter, your talent, skills, and time has a direct impact on people’s lives. Since 1931, we have been at the forefront of innovation by bringing smarter, more personalized care to patients around the world. Now, we’re more determined than ever to make a lasting impact as we are redefining healthcare delivery across the care journey. Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed. This is where you belong.