Regulatory Senior Associate Chemistry, Manufacturing, Controls (cmc)

Pfizer

Mexico City, Mexico
Hybrid (2-3 days per week in the office)
Chemistry manufacturing and control strategy
Global regulatory submission preparation
Ctd section development and finalization
Pfizer is seeking a Regulatory Senior Associate in Chemistry, Manufacturing, and Controls (CMC) to be based in Mexico City. This role involves developing regulatory strategies for pharmaceuticals and ensuring compliance with both local and global regulations

Job Summary

  • This role is critical for developing and implementing regulatory strategies for both small and large molecule pharmaceuticals at Pfizer.
  • The successful candidate will prepare and finalize Global Regulatory Strategy Documents and Clinical Data Request sections for submissions.
  • Pfizer is committed to bringing medicines to the world with speed while maintaining high standards of excellence and integrity.

Matching Summary

Match Score: 85

Pfizer is seeking a Regulatory Senior Associate in Chemistry, Manufacturing, and Controls (CMC) to be based in Mexico City. This role involves developing regulatory strategies for pharmaceuticals and ensuring compliance with both local and global regulations.

Skills & Requirements

Must-have

  • Chemistry Manufacturing and Control strategy
  • Global regulatory submission preparation
  • CTD section development and finalization
  • Compliance with local and global regulations
  • Cross-functional project management

Nice-to-have

  • Experience with small and large molecule pharmaceuticals
  • Proficiency in regulatory information management systems
  • Strong analytical and problem-solving skills
  • Project management experience
  • Curiosity for exploring AI tools like ChatGPT

Key Requirements

  • BA/BS with 2+ years experience or equivalent education/experience combinations
  • Sound understanding of regulatory processes for defined markets
  • Competent working knowledge of Microsoft Office and controlled documentation systems

Work Rights

Not specified

Tailored Resume

Cover Letter