Regulatory Affairs Specialist

2 months ago

Canada Organon LLC Full time
Job Summary

Organon LLC is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for providing regulatory support for our Network Projects.

Key Responsibilities
  • Lead the preparation and submission of CMC dossiers for assigned Network Projects.
  • Provide regulatory CMC support for Organon Network Projects, including oversight and monitoring of assigned CMC project timelines.
  • Collaborate with external partners to monitor, report, and act on delivery performance and quality of deliverables.
  • Develop and implement strategies to ensure timely and high-quality delivery of business commitments.
  • Escalate potential delays or performance issues to impacted stakeholders.
Requirements
  • Bachelor's degree in a science, engineering, or a related field.
  • Minimum 7 years of relevant experience in biological/pharmaceutical research, manufacturing, testing, or a related field.
  • Advanced degree (MS, MBA, Ph.D.) with minimum 4 years of relevant experience.
  • Strong negotiation, interpersonal, written/oral communication, and fluency in English language.
  • Project Management skills.
  • Good understanding of change management projects.
  • Degree in pharmacy, biopharmaceutics, analytical chemistry, organic chemistry, chemical engineering, or a related discipline.
  • Direct experience in Regulatory CMC.
  • Demonstrated experience driving change initiative projects.
About Organon LLC

Organon LLC is a global healthcare company focused on making a world of difference for women, their families, and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars, and touching lives with a diverse and trusted portfolio of health solutions.

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