Job Title:
Principal Scientist - CMC Pre-approval Regulatory
Cork, Ireland
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About the Role:
We are seeking a determined individual who is passionate about making life better for people around the world. At Lilly, we serve an extraordinary purpose. For over 140 years, we have worked tirelessly to discover medicines that improve lives.
We prioritize our work and put people first. Our team in Cork consists of talented and diverse professionals from 38 nationalities who deliver innovative solutions across various Business Service functions, including Finance, IT, Medical, Clinical Trials, and more.
Lilly Cork offers a premium workspace with flexible hybrid working options, comprehensive benefits, and holistic support for our colleagues' career development and wellbeing. We are committed to diversity, equity, and inclusion, ensuring equal opportunities for all ethnicities, nationalities, cultures, generations, sexuality, disabilities, and gender.
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Main Responsibilities:
1. Develop and prepare submission content and responses for clinical trials and marketing authorization applications.
2. Manage internal requirements and documentation within GRA and collaborate with internal partners (Development, TS/MS, Quality, etc).
3. Design and execute regulatory strategies and agreed-upon priorities through effective partnership with GRA-CMC Regulatory Scientists and other functional representatives.
4. Coordinate submission timelines with relevant teams (e.g., Development, TS/MS, Clinical Teams) and monitor approval status, communicating changes to interested personnel in a timely manner.
5. Collaborate with RDECMC Regulatory Associates to effectively support clinical trial and product submissions.
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Key Qualifications:
Bachelor's degree in Science, Engineering, or related field (Chemistry, Biology, Biochemistry, Pharmaceutics, Analytical Sciences, etc.) with 6-8 years experience in CMC regulatory or drug substance/drug product development, commercialization, manufacturing, or quality. Alternatively, Master's degree in Regulatory Affairs or related field with 3-5 years experience in drug substance/drug product development, commercialization, manufacturing, or quality. Less experience considered with PhD or Pharm D degree in related field.
Prior pharmaceutical industry experience in CMC technical drug development is desirable, as well as prior experience authoring CMC submission content, regulatory CMC experience, or equivalent combination of technical and regulatory guidance knowledge.
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Lilly is an equal opportunities employer, committed to diversity, equity, and inclusion.