Director, Sr Director, Executive Director Of Global Regulatory Affairs Chemistry, Manufacturing & Controls And Devices-latam/canada

Lilly

**
Global and latam/canada cmc regulatory requirements
Develop and lead cmc regulatory strategies
Liaise with regional regulatory agencies
** Lilly is seeking a Director, Sr Director, or Executive Director of Global Regulatory Affairs Chemistry, Manufacturing & Controls and Devices for the LATAM/Canada region. The role requires extensive regulatory expertise, leadership capabilities, and the ability to navigate complex drug development processes while fostering strong relationships with regulatory agencies and internal teams. **

Job Summary

  • 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 lifecycle maintenance in LATAM/Canada region.
  • 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).
  • Develop mutually productive relationships with regional regulatory agencies such as ANVISA (Brazil) and COFEPRIS (Mexico) to shape regional CMC regulatory environments and influence regional regulatory frameworks.

Matching Summary

Match Score: 75

** Lilly is seeking a Director, Sr Director, or Executive Director of Global Regulatory Affairs Chemistry, Manufacturing & Controls and Devices for the LATAM/Canada region. The role requires extensive regulatory expertise, leadership capabilities, and the ability to navigate complex drug development processes while fostering strong relationships with regulatory agencies and internal teams. **

Skills & Requirements

Must-have

  • Global and LATAM/Canada CMC regulatory requirements
  • Develop and lead CMC regulatory strategies
  • Liaise with regional regulatory agencies
  • Manage complex regulatory submission strategies
  • Technical decisions on CMC regulatory issues

Nice-to-have

  • Strong leadership behaviors
  • Mentoring affiliates and staff
  • Influence policy and emerging regulations
  • Proactive leadership role
  • Adapt to diverse interpersonal styles

Key Requirements

  • 7-10 years pharmaceutical industry experience
  • Minimum college degree (BSc)
  • Extensive prior Regulatory CMC experience
  • Demonstrated knowledge of CMC regulatory guidance
  • Fluent in English
  • Ability to work professionally in Spanish and/or Portuguese

Work Rights

Not specified

Tailored Resume

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