Manager, Regulatory Affairs

Baxter International; Chicago (IL); On-site; USD 120,000 - 165,000; Full time

Benefits offered by this job

Sign-on bonus

Comprehensive benefits package

Job summary

Baxter International seeks a Manager, Regulatory Affairs to develop and execute regulatory strategies across the product lifecycle. You will lead regulatory activities for product portfolios, ensuring timely submissions, approvals, and compliance across global requirements.

You will identify regulatory risks, guide cross-functional teams, and defend regulatory positions with sound scientific principles. This role also involves coaching a regulatory team and representing Baxter with health

Qualifications

• 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.
• Experience working directly with global health authorities and regulatory agencies.

Responsibilities

• 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 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.

Skills

Regulatory strategy

Cross-functional leadership

Regulatory submissions

Global regulatory knowledge

Risk assessment

Communication

Stakeholder management

People management

Product lifecycle knowledge

Multinational experience

Education

Bachelor’s degree in a scientific discipline

Job description

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

• 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.
• Experience working in multinational and multicultural business environments.

The $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 location, skills and expertise, experience, and other relevant factors.

US Benefits at Baxter (except for Puerto Rico)

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.

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.

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.