Manager, Regulatory Affairs

Baxter•Deerfield, IL

About The Position

The Manager, Regulatory Affairs develops and executes regulatory strategies that support business objectives throughout the product lifecycle. The role leads 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. It serves as a key liaison between Baxter, regulatory authorities, and internal stakeholders to drive successful regulatory outcomes. The position also leads, coaches, and develops regulatory team members and fosters a collaborative, high-performing environment. Baxter’s flexible workplace policy requires a minimum number of onsite days per week; that number is not specified. Applicants must be authorized to work for any employer in the United States, as visa sponsorship is unavailable.

Requirements

Bachelor’s degree in a scientific discipline or equivalent.
At least 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.
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, including coaching and developing team members.
Experience working in multinational and multicultural business environments.
Authorization to work for any employer in the United States; visa sponsorship is not available.

Responsibilities

Develop and execute regulatory strategies for new product development and lifecycle management aligned with business objectives.
Lead regulatory activities for assigned product portfolios, including submissions, approvals, and compliance commitments.
Identify regulatory risks, assess potential impacts, and implement mitigation strategies.
Monitor global regulatory requirements and ensure compliance with applicable regulations, standards, and Baxter procedures.
Conduct regulatory gap assessments and implement process improvements to improve 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.
Review and contribute to regulatory procedures and documentation to align 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, high-performing environment.

Benefits

$5,000 sign-on bonus for eligible external applicants, payable after the first 30 days at Baxter.
Medical and dental coverage starting on day one for eligible roles.
Basic life, accident, short-term and long-term disability, and business travel accident insurance.
Employee Stock Purchase Plan with the ability to purchase company stock at a discount.
401(k) Retirement Savings Plan with employee contributions and company matching.
Flexible Spending Accounts.
Educational assistance programs.
Paid holidays and paid time off ranging from 20 to 35 days based on length of service.
Family and medical leaves of absence and paid parental leave.
Commuting benefits.
Employee Discount Program.
Employee Assistance Program.
Childcare benefits.
Potential eligibility for discretionary bonuses.