Senior Regulatory Affairs Specialist

1 semana atrás


Lisboa, Lisboa, Portugal Biom?Rieux Bv Tempo inteiro
Job Description:

At Biom?Rieux Bv, we are seeking a highly skilled Sr. Scientist, Regulatory Affairs to join our team. The ideal candidate will have a strong background in regulatory chemistry, manufacturing, and controls (CMC) and be able to develop and implement global regulatory strategies for assigned products.

Key Responsibilities:


  • Develop and execute global regulatory strategies for assigned products.
  • Prepare and review information required for the development of regulatory CMC dossiers.
  • Collaborate with cross-functional teams to ensure product compliance.
  • Assess and communicate potential regulatory risks.
  • Manage multiple projects to ensure timely submissions.

Requirements:


  • Bachelor's or advanced degree in a science, engineering, or related field.
  • Minimum 2 years of relevant CMC experience.
  • Strong analytical and communication skills.
  • Experience with regulatory guidelines and documentation.

Preferred Qualifications:


  • Direct experience in Regulatory CMC and/or authoring of regulatory documentation.
  • Device and/or combination product regulatory experience.



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