Regulatory Affairs Expert

Há 1 mês


Lisboa, Lisboa, Portugal Organon Tempo inteiro
Job Summary

Organon seeks a highly skilled Regulatory Affairs Expert to join its team. As a key member of our regulatory department, you will be responsible for implementing regulatory strategies for assigned products, ensuring compliance with global regulations and guidelines.

Key Responsibilities:

  • Develop and implement regulatory strategies for assigned products, ensuring alignment with global regulations and guidelines.
  • Lead the development of CMC submission components and documentation, ensuring timely and accurate maintenance of CMC submissions.
  • Liaise with internal stakeholders 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.

Requirements:

  • Bachelor's degree in a science, engineering, or related field with at least four years of relevant work experience or an advanced degree with at least two years of relevant work experience.
  • Minimum of two years of relevant CMC experience, including biological/pharmaceutical research, manufacturing, testing, or a related field.
  • Proficiency in English; additional language skills are a plus.

About Organon:

Organon is a $6.5 billion global healthcare company focused on making a world of difference for women, their families, and the communities they care for.



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