Principal Specialist, Regulatory Affairs

About the role

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.

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.

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.