Sr. Principal Scientist, Advisor, Sr. Advisor Of Global Regulatory Affairs Chemistry, Manufacturing & Controls And Devices-emea

Lilly

Not specified (potentially hybrid or fully remote based on the global nature of the role).
Emea regulatory strategy
Cmc drug development
Regulatory submissions emea
Lilly is seeking a Sr. Principal Scientist, Advisor, Sr. Advisor of Global Regulatory Affairs Chemistry, Manufacturing & Controls and Devices for the EMEA region. The position demands extensive knowledge of CMC drug development and regulatory strategies to facilitate successful market registrations and product lifecycle maintenance

Job Summary

  • The purpose of the Sr. Principal Scientist, Advisor, Sr. Advisor of Global Regulatory Affairs Chemistry, Manufacturing & Controls and Devices-EMEA is to provide strategic, tactical, and operational direction to expedite CMC development of Lilly’s portfolio and to develop successful regulatory strategies to support market registrations and product life-cycle maintenance in EMEA region.
  • This role requires a strong working knowledge of global and EMEA-regional regulations, guidelines and regulatory precedence coupled with a strong technical knowledge of development and manufacturing processes.
  • The scientist will develop collegial and mutually productive relationships across Lilly components, partner with broader GRA-CMCD, GRA regional teams and regional affiliates, Manufacturing and Quality (M&Q), and Product Research & Development (PR&D).

Matching Summary

Match Score: 85

Lilly is seeking a Sr. Principal Scientist, Advisor, Sr. Advisor of Global Regulatory Affairs Chemistry, Manufacturing & Controls and Devices for the EMEA region. The position demands extensive knowledge of CMC drug development and regulatory strategies to facilitate successful market registrations and product lifecycle maintenance.

Skills & Requirements

Must-have

  • EMEA regulatory strategy
  • CMC drug development
  • regulatory submissions EMEA
  • manufacturing quality systems
  • technical drug development

Nice-to-have

  • strategic and tactical direction
  • life-changing medicines
  • caring and discovery
  • functional mentor or peer coach

Key Requirements

  • Minimum 4 years pharmaceutical industry experience
  • Minimum college degree (BSc)
  • Prior Regulatory CMC experience (5-8 years)
  • Full professional proficiency in English

Work Rights

Not specified

Tailored Resume

Cover Letter