Pfizer is seeking a Regulatory Senior Associate in Chemistry, Manufacturing, and Controls (CMC) in Mexico City, requiring 2-3 days of onsite work weekly. The role involves developing and implementing regulatory strategies for pharmaceuticals, ensuring compliance with global standards, and contributing to cross-functional initiatives
Job Summary
This role is critical for developing and implementing regulatory strategies to accelerate patient access to Pfizer's innovative medicines.
The successful candidate will prepare and finalize Global Regulatory Strategy Documents and Clinical Data Request sections for submissions.
Pfizer seeks a dedicated professional who can independently manage projects while ensuring strict adherence to ethical practices and quality compliance.
Matching Summary
Match Score: 85
Pfizer is seeking a Regulatory Senior Associate in Chemistry, Manufacturing, and Controls (CMC) in Mexico City, requiring 2-3 days of onsite work weekly. The role involves developing and implementing regulatory strategies for pharmaceuticals, ensuring compliance with global standards, and contributing to cross-functional initiatives.
Skills & Requirements
Must-have
Chemistry Manufacturing Controls strategy
Global regulatory submission preparation
CTD section authoring
Health authority liaison
Compliance with global regulations
Nice-to-have
Experience with small and large molecules
Project management capabilities
Generative AI tool proficiency
Cross-functional collaboration skills
Curiosity for responsible AI practices
Key Requirements
BA/BS with 2+ years experience or equivalent education/experience mix
Sound understanding of regulatory processes for defined markets
Competent working knowledge of Microsoft Office and controlled documentation systems