Global Regulatory Strategy Lead

Baxter Healthcare; Deerfield (IL); On-site; USD 104,000 - 143,000; Full time

Benefits offered by this job

Medical and dental coverage from day 1

Employee stock purchase plan (ESPP)

401(k) with company match

Paid time off 20–35 days; paid holiday

Job summary

Baxter Healthcare is seeking a Regulatory Affairs professional to develop and drive global regulatory strategies for pharmaceutical products within Infusion Therapies and Platforms. You will collaborate with cross-functional teams to navigate complex requirements, ensuring timely market access worldwide.

The role focuses on lifecycle management, submissions, and leadership to meet evolving regulatory standards across global markets. Strong negotiation and multinational experience are essential.

Qualifications

• Bachelor's degree in a scientific discipline or equivalent country-specific qualification.
• 5+ years of Regulatory Affairs or related experience in pharma/medical devices/CRO or similar regulated industry.
• Strong knowledge of global regulatory requirements and product registration processes.
• Demonstrated project management skills with ability to manage multiple priorities and deadlines.
• Excellent written and verbal communication and collaboration skills.

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.

Skills

Regulatory Affairs

Global submissions

Project management

Cross-functional collaboration

Health authority negotiations

Education

Bachelor's degree in a scientific discipline

Tools

Document management systems

Databases

Online research tools

Job description

Baxter Healthcare is seeking a Regulatory Affairs professional to develop and drive global regulatory strategies for pharmaceutical products within Infusion Therapies and Platforms. You will collaborate with cross-functional teams to navigate complex requirements, ensuring timely market access worldwide.

The role focuses on lifecycle management, submissions, and leadership to meet evolving regulatory standards across global markets. Strong negotiation and multinational experience are essential.