Lead E&L Scientist – Research & Regulatory Strategy

Baxter International Inc.

Eigenbrakel

On-site

EUR 120,000 - 180,000

Full time

5 hours ago
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Job summary

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

You will build and mentor a high‑performing team of Study Directors, drive strategic directions for E&L programs, and partner with regulatory affairs, toxicology, quality and manufacturing to enable regulatory submissions and product development.

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.
  • Excellent communication skills and the ability to proactively engage diverse stakeholder groups.

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 experience
E&L program expertise
Regulatory submissions
Strategic thinking
Cross-functional collaboration
Communication skills
Project management

Job description

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

You will build and mentor a high‑performing team of Study Directors, drive strategic directions for E&L programs, and partner with regulatory affairs, toxicology, quality and manufacturing to enable regulatory submissions and product development.

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