Lead E&L Scientist - Regulatory Strategy

Baxter International Inc.; Eigenbrakel; On-site; EUR 90,000 - 130,000; Full time

Job summary

Baxter International Inc. in Belgium is seeking an experienced Research Scientist II – E&L Team Lead to guide a global E&L program in medical devices, pharmaceuticals and combination products.

You will lead a team of study directors, shape regulatory strategy, and collaborate with R&D, Regulatory Affairs, and external labs to deliver robust, regulatory‑defensible science and high‑impact outcomes.

Qualifications

• Proven leadership experience managing and developing technical or scientific teams.
• Strong experience in Extractables & Leachables (E&L) programs and how E&L data supports regulatory submissions.
• The ability to translate complex scientific findings into clear business and regulatory recommendations.
• Experience influencing stakeholders across multiple functions and organizational levels.
• Strong strategic thinking and decision‑making skills in complex, highly regulated environments.
• Experience managing multiple projects, priorities and resources simultaneously.

Responsibilities

• Lead and develop a team of E&L Study Directors, fostering technical excellence, engagement and professional growth.
• Drive the strategic direction of E&L programs supporting medical devices, pharmaceutical products and combination products.
• Partner with global cross‑functional teams to ensure E&L strategies support product development, lifecycle management and regulatory submissions.
• Serve as a recognized technical leader and trusted advisor on E&L topics across the organization.
• Guide complex scientific and regulatory decisions while balancing business objectives, risk management and compliance requirements.
• Review and approve study designs, technical assessments, protocols and reports to ensure scientific rigor and regulatory defensibility.
• Build organizational capabilities in E&L science, analytical characterization and toxicological risk assessment.
• Represent Baxter during regulatory interactions, audits, inspections and customer discussions related to E&L activities.
• Develop strong partnerships with external laboratories and ensure delivery of high-quality scientific outcomes.
• Identify opportunities to improve processes, strengthen capabilities and enhance operational efficiency across the E&L function.

Skills

Leadership

E&L programs

Regulatory submissions

Stakeholder influence

Strategic thinking

Team development

Tools

Mass spectrometry

Data interpretation

Job description

Baxter International Inc. in Belgium is seeking an experienced Research Scientist II – E&L Team Lead to guide a global E&L program in medical devices, pharmaceuticals and combination products.

You will lead a team of study directors, shape regulatory strategy, and collaborate with R&D, Regulatory Affairs, and external labs to deliver robust, regulatory‑defensible science and high‑impact outcomes.