Principal Specialist, Regulatory Affairs

Baxter • Deerfield, IL

3d

About The Position

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Your role at Baxter As a Regulatory Affairs professional at Baxter, you will play a critical role in developing and driving global regulatory strategies that support the successful registration, maintenance, and lifecycle management of pharmaceutical products within Baxter's Infusion Therapies and Platforms business. You will partner with cross-functional teams to navigate complex regulatory requirements, ensure compliance, and drive timely market access for products across global markets. This is where your regulatory expertise and strategic insight help bring life-saving therapies to patients by ensuring products meet evolving global regulatory requirements and maintain marketing authorizations worldwide. Success in this role is measured by the timely execution of regulatory submissions, effective management of regulatory risks, successful interactions with health authorities, and your ability to provide regulatory leadership that supports business objectives and product development initiatives.

Requirements

• Bachelor's degree in a scientific discipline or equivalent country-specific qualification.
• Minimum of 5 years of Regulatory Affairs or related experience within the pharmaceutical, medical device, CRO, or similar regulated industry.
• Strong knowledge of global regulatory requirements and product registration processes.
• Demonstrated project management skills with the ability to manage multiple priorities and deadlines.
• Excellent written and verbal communication, and collaboration skills
• Ability to identify compliance risks and appropriately bring up issues when necessary.
• Experience supporting pharmaceutical products and global regulatory submissions.
• Strong negotiation and health authority interaction experience.
• Experience working in multinational and multicultural business environments.
• Proficiency with regulatory information systems and standard business software applications, including document management systems, databases, and online research tools.
• Demonstrated ability to influence cross-functional teams and provide mentorship to junior regulatory professionals.
• 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.

Responsibilities

• Develop and implement complex global regulatory strategies and project plans to support product registrations and lifecycle management activities.
• Identify, assess, and communicate regulatory risks while providing strategic regulatory guidance to cross-functional project teams.
• Prepare, review, compile, and submit regulatory documentation to health authorities in accordance with applicable regulatory requirements and timelines.
• Respond to complex regulatory authority inquiries and negotiate regulatory outcomes to support business objectives.
• Maintain and update existing marketing authorizations and regulatory licenses across global markets.
• Lead or represent Regulatory Affairs on product development and lifecycle management teams, ensuring compliance with applicable regulations.
• Review and approve labeling, regulatory documentation, and standard operating procedures (SOPs).
• Monitor global regulatory developments, maintain regulatory filing systems, and provide coaching and guidance to less experienced team members.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Principal