Regulatory Affairs Senior Specialist

Há 2 dias


Lisboa, Lisboa, Portugal Biom?Rieux Bv Tempo inteiro

At Biom?Rieux Bv, we are seeking a highly skilled Regulatory Affairs Senior Specialist to join our team. This role is responsible for implementing regulatory strategies for assigned products in accordance with global regulations and guidelines. The ideal candidate will have a strong background in chemistry, manufacturing, and controls (CMC) and be proficient in English.

Job Summary

We are looking for a motivated and experienced Regulatory Affairs Senior Specialist to support the preparation and review of information required for development of regulatory CMC dossiers for life-cycle maintenance submissions and post-approval changes. The successful candidate will provide input to global product and project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements, and critically evaluating supporting documentation.

Main 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 to support post-approval supplements and responses to health authority questions.
  • Ensure product compliance through timely and accurate maintenance of CMC submissions in the systems.
  • Liaise with our Company's Manufacturing & Supply colleagues and external partners to support compliant execution of change management.
  • Assess and communicate potential regulatory risks and propose mitigation strategies.
  • Deliver all regulatory milestones for assigned products across the product lifecycle.
  • Identify and communicate potential regulatory issues to our company's Regulatory CMC management, as needed.

Requirements:

  • Bachelor's degree in a science, engineering, or related scientific field with at least four years of overall relevant work experience.
  • Advanced degree (MS, MBA, Ph.D., PharmD) 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.
  • Proficient in English; additional language skills are a plus.
  • Familiar with regulatory guidelines for product post-approval change management and data requirements.
  • Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner.

Salary:$120,000 - $150,000 per year, depending on experience

This is a full-time position based in [location]. We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.

At Biom?Rieux Bv, we value diversity and inclusion. We are an equal opportunity employer and welcome applications from candidates with diverse backgrounds.



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