Sr. Principal Scientist - Regulatory Gra-cmcd

Eli Lilly

Little Island, Ireland
Not specified; not specified; benefits include hea...
Hybrid
Global cmc regulatory requirements knowledge
Post-approval change management strategy
Manufacturing sciences and gmp expertise
The role provides strategic direction to develop effective post-approval CMC regulatory strategies across the global commercial portfolio

Job Summary

  • The role provides strategic direction to develop effective post-approval CMC regulatory strategies across the global commercial portfolio.
  • Eli Lilly Cork offers a premium workspace with flexible hybrid working options, healthcare, pension, and onsite gym benefits.
  • The scientist must utilize deep technical knowledge of pharmaceutical manufacturing to drive internal consistency and influence effective change management.

Matching Summary

The role provides strategic direction to develop effective post-approval CMC regulatory strategies across the global commercial portfolio.

Salary

Not specified; Not specified; Benefits include healthcare, pension, life assurance, subsidised canteen, onsite gym, travel subsidies, and parking

Skills & Requirements

Must-have

  • Global CMC regulatory requirements knowledge
  • Post-approval change management strategy
  • Manufacturing sciences and GMP expertise
  • Biotech molecule development portfolio experience
  • Risk-based change control assessment

Nice-to-have

  • Digital tools and AI/ML applications
  • Cross-functional leadership and mentoring
  • Industry organization participation
  • Process simplification initiatives
  • Strong written and verbal communication

Key Requirements

  • BSc, MSc, PharmD, or PhD in Chemistry, Pharmacy, Biology, Biochemistry
  • 7–10 years pharmaceutical industry manufacturing experience
  • 3–7 years prior regulatory CMC experience
  • Demonstrated ability to work independently on complex problems

Work Rights

Not specified

Tailored Resume

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