Senior Specialist Regulatory Affairs

☞ Baxter International Inc.

見る: 195

更新日: 26-11-2025

場所: Braine-l’Alleud Walloon Brabant

カテゴリー: 法務/契約

業界: Medical Equipment Manufacturing

レベル: Associate

ジョブタイプ: Full-time

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仕事内容

Req # JR - 060126 Location Braine-l’Alleud, Wallonia, Belgium Job Category Regulatory Affairs Date posted 02/23/2022

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Summary

Under limited supervision responsible for the implementation of global regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of Baxter’s products. Support regulatory activities relating to specific portfolio of global products/projects.

Essential Duties And Responsibilities
  • With direction, develop and execute regulatory project plans
  • Identify and elevate key areas of regulatory risk
  • Maintain regulatory files in a format consistent with requirements and perform MoH submissions
  • Maintain awareness of regulatory requirements; identify relevant requirements
  • Participate as an active team member and provide regulatory advice to project teams as required
  • Respond to questions from regulatory authorities within strict timelines
  • Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
  • Maintain and update existing regulatory authorizations
  • Support regulatory activities relating to specific portfolio of products/projects
  • Prepare, review, and approve labeling and SOP’s
  • Represent or lead Regulatory Affairs in small project teams
Qualifications
  • Knowledge of regulations
  • Scientific knowledge
  • Project management skills
  • Manage multiple projects and deadlines
  • Ability to multitask and prioritize
  • Interpersonal and communication skills
  • Negotiation skills
  • Technical system skills (e.g. word processing, spreadsheets, databases, online research)
  • Ability to identify compliance risks and escalate when necessary
Education And/or Experience

Bachelor’s degree or country equivalent in a scientific discipline

Minimum of 2 years regulatory experience in drugs within a pharmaceutical company, CRO, or similar organization.

Experience in EU regulations and submissions will be a plus.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our

060126
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締切: 10-01-2026

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