Manager, Regulatory Affairs
Baxter International Inc.
Summary
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.
Job description
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.
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 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.
Benefits
- Medical, Dental & Vision
- Life Insurance
- Accident Insurance
- Short-term Disability
- Long-term Disability
- Business Travel Accident Insurance
- Employee Stock Purchase Plan
- 401(k) Matching
- Flexible Spending Accounts
- Educational Assistance
- Paid Holidays
- Paid Time Off
- Family & Medical Leave
- Paid Parental Leave
- Commuting Benefits
- Employee Discount Program
- Employee Assistance Program
- Childcare Benefits
- $5,000 Sign-on Bonus
Company overview
Baxter International Inc. is an American multinational healthcare company headquartered in Deerfield, Illinois, founded in 1931. As a leading global medical device manufacturer, Baxter specializes in developing and producing essential medical products for treating chronic and acute medical conditions. The company operates across three primary business segments: Medical Products and Therapies, Healthcare Systems and Technologies, and Pharmaceuticals. Baxter's extensive product portfolio includes intravenous (IV) solutions, infusion pumps, dialysis equipment for kidney disease treatment, surgical technologies, and hospital pharmaceuticals. With approximately 38,000 employees worldwide and annual revenues exceeding $10 billion, Baxter plays a critical role in global healthcare infrastructure. The company is particularly known for its leadership in IV fluid production, manufacturing approximately 60% of the intravenous fluids used in the United States. Baxter's innovations include pioneering developments in artificial kidney technology and advanced surgical products, serving healthcare providers across more than 100 countries. The company maintains a strong commitment to research and development, investing significantly in medical technology advancements that improve patient outcomes and healthcare delivery efficiency.