Scientific Regulatory Affairs Expert

3 semanas atrás


Lisboa, Lisboa, Portugal Biom?Rieux Bv Tempo inteiro

Job Overview

Biom?Rieux Bv is seeking an experienced Scientific Regulatory Affairs Expert to join our team. In this role, you will be responsible for implementing regulatory strategies for assigned products in accordance with global regulations and guidance.

Key Responsibilities

  • Provide input to global product and project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements, and critically evaluating supporting documentation.
  • Execute global regulatory strategies by leading the development, authoring, and review of CMC submission components and documentation.
  • Ensure product compliance through timely and accurate maintenance of CMC submissions.
  • Liaise with our Company's Manufacturing & Supply colleagues and external partners to support compliance execution of change management.

Required Skills and Qualifications

  • Bachelor's degree in a science, engineering, or a related scientific field with at least four years of overall relevant work experience OR advanced degree in a science, engineering, or related scientific field with at least two years of overall relevant work experience.
  • Minimum of two (2) years of relevant CMC experience, including biological/pharmaceutical research; manufacturing, testing, or a related field.
  • Strong understanding of related fields such as pharmaceutical manufacturing, analytical testing, and quality assurance.
  • Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.

Estimated Salary

$120,000 - $180,000 per year, depending on experience.

About Us

Biom?Rieux Bv is a global healthcare company focused on making a world of difference for women, their families, and the communities they care for. We are committed to creating an inclusive environment for all our applicants and welcome applications from candidates with a diverse background.



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