Global Regulatory Affairs Manager — Strategy & Submissions

Baxter International Inc.; Deerfield (IL); Hybrid; USD 120,000 - 165,000; Full time

Benefits offered by this job

Sign-on bonus $5,000

Job summary

Baxter International Inc. is seeking a Manager, Regulatory Affairs to develop and execute regulatory strategies across the product lifecycle.

You will lead regulatory activities for multiple product portfolios and collaborate with global teams to ensure timely submissions and compliant outcomes. The role requires 5+ years in Regulatory Affairs, strong leadership, and deep knowledge of global regulatory requirements.

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.
• 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.

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 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.

Skills

Regulatory affairs

Project leadership

Global regulatory

Lifecycle management

Regulatory submissions

Stakeholder management

Cross-functional teamwork

Health authorities

Education

Bachelor's degree in a scientific discipline

Job description

Baxter International Inc. is seeking a Manager, Regulatory Affairs to develop and execute regulatory strategies across the product lifecycle.

You will lead regulatory activities for multiple product portfolios and collaborate with global teams to ensure timely submissions and compliant outcomes. The role requires 5+ years in Regulatory Affairs, strong leadership, and deep knowledge of global regulatory requirements.