Senior Regulatory Affairs Specialist

2 days ago


Marquand, Missouri, United States Eli Lilly Full time
Job Title: Senior Regulatory Affairs Specialist

Eli Lilly is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team in Indianapolis, Indiana. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with global regulatory requirements and guidelines related to parenteral drug product manufacturing and obtaining global product marketing registrations.

Key Responsibilities:
  • Develop and implement regulatory strategies to ensure alignment with current and evolving global regulatory expectations
  • Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development or product lifecycle planning
  • Lead preparation, review, and finalization of CMC documents for global CTA and registration submissions and response to questions
  • Take a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content
Requirements:
  • B.S. degree in a science, engineering, or a related field (Chemistry, Biology, Biochemistry, Pharmaceutics, Engineering, Analytical Sciences, or similar) with a minimum of 15 years of regulatory CMC experience or equivalent
  • Advanced degree (PhD, MS) in a science, engineering or related field (Chemistry, Biology, Biochemistry, Pharmaceutics, Engineering, Analytical Sciences, or similar) with a minimum of 4 years of regulatory CMC experience
Preferred Experiences and Skills:
  • Experience in biotechnology drug substance and/or drug product development, commercialization or manufacturing
  • Demonstrated deep knowledge of the biologic drug development process
  • Bioproduct Regulatory CMC experience supporting clinical phases of development and/or commercialization, experience should include authoring CMC submission content, and involvement in clinical trial and commercial processes including response to questions


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