Sr Mgr, Regulatory Affairs

Baxter International Inc.•Deerfield, IL

7d•$152,000 - $209,000•Onsite

About The Position

A Senior Manager of Global Regulatory Affairs leads the development and execution of regulatory strategies to support product approvals, lifecycle management, and compliance across international markets, with deep expertise in US FDA requirements. This role coordinates cross‑functional teams to prepare, review, and submit high‑quality regulatory filings, ensuring alignment with evolving global and US regulations. They serve as a strategic advisor to leadership, providing risk‑based guidance and driving regulatory excellence to enable timely market access and sustained product compliance.

Requirements

Bachelor’s degree or country equivalent in a scientific discipline
Minimum of 7-year experience in RA
Expert Regulatory knowledge
Sound basis of Scientific (Training/ Communications) knowledge
Management skills
Ability to oversee multiple projects in a matrix team environment
Excellent oral and written communication and presentation skills
Demonstrated excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities
Technical and management skills
Ability to lead, coach, and motivate others
Ability to accomplish results through others
Ability to work effectively in multinational/multicultural environment
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

Nice To Haves

Master’s and/or PhD will be preferred

Responsibilities

Serves as the Global Regulatory Lead for Baxter’s hemostat and sealant product(s) registered as biologic/combination products
Provide technical and strategic input for regulatory decisions aligned with business strategy
Identify & prioritize key areas of risk and probability of occurrence as well as ensure implementation of mitigation plans and follow ups
Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with Baxter and external standards
Assess impact of new regulations and provide feedback
Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks
Act as primary contact for meetings with regulatory authorities including planning and leadership
Maintain appropriate communication within the RA function, with Global Marketing, and with other functions primarily at the project team level
Plan and manage complex projects and prioritize workload
Initiate, manage and maintain operational activities in support of new and existing marketing authorizations
Set team, group, or service objectives to assure they align with the regulatory strategy
Represent Baxter interests in industry and working groups
Mentor junior colleagues on US regulatory requirements and submission strategies

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