Regulatory Senior Associate Chemistry, Manufacturing, Controls (CMC)

Location: Mexico City, Mexico; hybrid work arrangement

Company

hirify.global develops medicines and vaccines and works to expand patient access while maintaining scientific, regulatory, and ethical standards.

What you will do

• Develop and implement regulatory CMC strategies for small and large molecule pharmaceuticals.
• Assemble CMC information for global regulatory submissions and prepare CTD sections.
• Prepare and finalize global regulatory strategy documents.
• Maintain core dossiers, coordinate responses to deficiency letters, and support renewals.
• Review regulatory guidelines and ensure compliance with submission standards, procedures, and policies.
• Manage projects independently, mitigate risks, resolve issues, and collaborate with cross-functional teams.

Requirements

• Bachelor's degree with 2+ years of experience, master's degree or MBA with 0+ years, associate degree with 6+ years, or high school diploma with 8+ years of relevant experience.
• Understanding of regulatory processes and requirements for defined markets, with the ability to apply them to projects.
• Commitment to scientific and regulatory integrity, quality compliance, and sound decision-making.
• Ability to navigate tracking and change-control systems and support consistent system use.
• Ability to contribute to teams, implement change, and resolve problems in standard situations.
• Working knowledge of Microsoft Office and controlled documentation systems.

Nice to have

• Pharmaceutical industry experience.
• Regulatory CMC strategy experience for small and large molecule pharmaceuticals.
• Experience with regulatory information management systems.
• Strong analytical, problem-solving, and project management skills.
• Experience using generative AI tools such as ChatGPT or Microsoft Copilot, with awareness of responsible AI practices.

Culture & Benefits

• Hybrid work arrangement.
• Focus on scientific integrity, ethical practices, quality, and patient access.
• Equal employment opportunity for employees and applicants.