Global Regulatory Strategy Manager

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

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