Senior Regulatory Affairs Specialist

4 weeks ago

Canada Organon LLC Full time
Job Title: Associate Director, Regulatory CMC

Organon LLC is seeking an experienced Associate Director to lead our Regulatory CMC team. As a key member of our organization, you will be responsible for providing regulatory CMC support for our network projects.

Key Responsibilities:
  • Lead the preparation and submission of CMC dossiers for assigned network projects
  • Collaborate with internal and external partners to drive on-time, high-quality delivery of business commitments
  • Monitor, facilitate, report, and communicate progress against agreed timelines
  • Escalate potential delays or performance issues to impacted stakeholders
  • Provide CMC support for Legal Entity Change (LEC) project
Requirements:
  • Bachelor's degree in a science, engineering, or related field
  • Minimum 7 years of relevant experience in biological/pharmaceutical research, manufacturing, testing, or a related field
  • Or 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
  • 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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