Sr. Principal Scientist - Regulatory Gra-cmcd

Eli Lilly

Little Island, Ireland
Not specified; not specified; benefits: healthcare...
Hybrid
Global cmc regulatory requirements knowledge
Post-approval change management strategies
Manufacturing science and technology expertise
The role provides strategic direction for Eli Lilly's global commercial portfolio by developing effective post-approval CMC regulatory strategies

Job Summary

  • The role provides strategic direction for Eli Lilly's global commercial portfolio by developing effective post-approval CMC regulatory strategies.
  • Eli Lilly Cork offers a premium workspace with flexible hybrid working options, onsite gym, subsidized canteen, and comprehensive benefits including pension and life assurance.
  • The position requires leading complex regulatory assessments and collaborating with manufacturing sites, quality teams, and health authorities to ensure timely submission milestones.

Matching Summary

The role provides strategic direction for Eli Lilly's global commercial portfolio by developing effective post-approval CMC regulatory strategies.

Salary

Not specified; Not specified; Benefits: healthcare, pension, life assurance, subsidised canteen, onsite gym, travel subsidies, on-site parking

Skills & Requirements

Must-have

  • Global CMC regulatory requirements knowledge
  • Post-approval change management strategies
  • Manufacturing science and technology expertise
  • GMP compliance and lifecycle innovation
  • Cross-functional team leadership skills

Nice-to-have

  • Digital tools and AI/ML applications experience
  • Industry organization leadership participation
  • Strong mentoring and coaching abilities
  • Process simplification and efficiency initiatives

Key Requirements

  • BSc, MSc, PharmD, or PhD in scientific discipline
  • 7-10 years pharmaceutical industry manufacturing experience
  • 3-7 years prior regulatory CMC experience
  • Demonstrated strong interpersonal and leadership skills

Work Rights

Not specified

Tailored Resume

Cover Letter