Sr. Principal Scientist - Regulatory Gra-cmcd

Eli Lilly UK

Cork, Ireland
Hybrid
Global cmc regulatory expertise
Pharmaceutical manufacturing technology knowledge
Post-approval change management
Eli Lilly Cork offers a premium workspace with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking

Job Summary

  • Eli Lilly Cork offers a premium workspace with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking.
  • The Sr. Principal Scientist role provides strategic, tactical, and operational direction to support Lilly’s marketed portfolio by developing successful regulatory strategies and submissions globally.
  • The company is committed to diversity, equity and inclusion, supporting all dimensions including disabilities, and promotes a disability confident culture.

Matching Summary

Eli Lilly Cork offers a premium workspace with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking.

Skills & Requirements

Must-have

  • Global CMC regulatory expertise
  • Pharmaceutical manufacturing technology knowledge
  • Post-approval change management
  • Regulatory submission preparation and review
  • Lifecycle regulatory strategy development
  • Risk-based regulatory assessments
  • Cross-functional collaboration

Nice-to-have

  • Digital tools and automation experience
  • Leadership and mentoring skills
  • Experience with AI/ML applications
  • Change initiative support
  • Strong communication skills
  • Diversity, equity, and inclusion commitment

Key Requirements

  • BSc, MSc, PharmD, or PhD in related scientific discipline
  • 7–10 years pharmaceutical manufacturing experience
  • 3–7 years regulatory CMC experience
  • Strong understanding of global CMC regulations and GMP
  • Experience with change control and deviation assessments
  • Ability to deliver projects on agreed timelines

Work Rights

Not specified

Tailored Resume

Cover Letter