Associate - Global Regulatory Affairs Chemistry, Manufacturing & Controls And Devices-latam/canada

Lifestylelily

Not specified
Latam/canada cmc regulatory requirements
Cmc drug development science
Regulatory strategy development
Lilly is seeking an Associate for Global Regulatory Affairs focused on Chemistry, Manufacturing, and Controls (CMC) and Devices in the LATAM/Canada region. The ideal candidate will have a strong background in regulatory compliance, drug development, and experience with CMC submissions in the pharmaceutical industry

Job Summary

  • The purpose of this role is to provide strategic, tactical, and operational direction to expedite CMC development and develop successful regulatory strategies for market registrations and product life-cycle maintenance in the LATAM/Canada region.
  • This role requires developing mutually productive relationships with internal teams and regional regulatory agencies to shape regional CMC regulatory environments and influence the regulatory framework.
  • Key responsibilities include managing regulatory strategy, providing regulatory advice, evaluating regulatory impact of development plans, and coordinating the preparation and review of CMC documents for submissions.

Matching Summary

Match Score: 80

Lilly is seeking an Associate for Global Regulatory Affairs focused on Chemistry, Manufacturing, and Controls (CMC) and Devices in the LATAM/Canada region. The ideal candidate will have a strong background in regulatory compliance, drug development, and experience with CMC submissions in the pharmaceutical industry.

Skills & Requirements

Must-have

  • LATAM/Canada CMC regulatory requirements
  • CMC drug development science
  • Regulatory strategy development
  • Develop regulatory strategies
  • Manufacturing quality systems

Nice-to-have

  • Shape regional regulatory environments
  • Influence regional regulatory framework
  • Functional mentor or peer coach
  • Develop collegial relationships
  • Industry organizations participation

Key Requirements

  • Minimum college degree (BSc)
  • 4 years pharmaceutical industry experience
  • Prior Regulatory CMC experience (5-8 years)
  • Fluent in English
  • Spanish and/or Portuguese proficiency

Work Rights

Not specified

Tailored Resume

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