Regulatory Senior Associate Chemistry, Manufacturing, Controls (CMC)
Pfizer · Mexico City, Mexico
RegulatoryFull-timeCompany career page
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Role summary
Regulatory Senior Associate role focused on Chemistry, Manufacturing, and Controls strategy for pharmaceutical submissions. Develops regulatory strategies, assembles CMC documentation for global submissions, manages dossiers, and coordinates with health authorities to ensure compliance with regulatory requirements.
What they're looking for
- Bachelor's degree with 2+ years relevant experience, or Master's degree, or associate degree with 6+ years experience
- Demonstrated commitment to scientific integrity, regulatory compliance, and quality standards
- Sound understanding of regulatory processes and ability to interpret requirements for defined markets
- Proficiency with tracking systems, change control systems, and Microsoft Office
- Strong integrity in regulatory decision-making aligned with company values
- Ability to contribute effectively to cross-functional teams and resolve standard problems
What you'll be doing
- Develop and implement regulatory strategies for small and large molecule pharmaceuticals
- Assemble Chemistry, Manufacturing, and Control information for global regulatory submissions and CTD sections
- Maintain core dossiers and coordinate responses to regulatory deficiency letters
- Collaborate with cross-functional teams to support regulatory strategies and mitigate project risks
- Independently manage projects and execute regulatory strategies with minimal oversight
Privacy & handoff
This role links to Pfizer's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.