Principal Regulatory Affairs Expert

Há 2 dias


Lisboa, Lisboa, Portugal Organon Tempo inteiro

Job Overview

The Associate Principal Scientist, Regulatory Affairs, Chemistry Manufacturing and Controls position at Organon is a key role in facilitating and implementing global regulatory strategies for small molecule products. This expert will work closely with the CMC Product Lead to ensure the successful execution of project milestones.

Responsibilities:

  • Collaborate with the CMC Product Lead to develop and execute global product and project regulatory strategies.
  • Provide input to global product and project regulatory strategies by assessing CMC changes, identifying global regulatory requirements, and critically evaluating supporting documentation.
  • Lead the development and execution of global product and project regulatory strategies by ensuring robust assessment of CMC changes and identification of global regulatory requirements.
  • Execute 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.
  • Collaborate with manufacturing and supply colleagues and external partners to ensure compliant execution of change management.
  • Manage execution of CMC documentation including post-approval supplements and responses to health authority questions.
  • Ensure timely and accurate maintenance of CMC submissions in systems.
  • Demonstrate an understanding of regulatory affairs and apply this understanding to ensure approval and product supply continuity.
  • Assess and communicate potential regulatory risks and propose mitigation strategies.
  • Deliver all regulatory milestones for assigned projects.

Requirements:

Bachelor's degree in a science, engineering, or related field (Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry) with at least 7 years of relevant experience, or Advanced degree (MS, MBA, Ph.D). Relevant experience includes biological/pharmaceutical research, manufacturing, testing, or a related field.

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


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