Manager, Regulatory Affairs

Baxter International Inc.•Deerfield, IL

1d•$120,000 - $165,000•Hybrid

About The Position

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.

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.

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.

Benefits

medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
educational assistance programs
paid holidays
paid time off ranging from 20 to 35 days based on length of service
family and medical leaves of absence
paid parental leave
commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
childcare benefits