Regulatory Affairs Specialist - Mexico Compliance & Submissions

Sandoz; Ciudad de México; On-site; MXN 60,000 - 90,000; Full time

Job summary

Sandoz Mexico City is seeking a Regulatory Affairs professional to maintain portfolio regulatory tasks, coordinate submissions, and ensure product continuity with the authorities.

Responsibilities include managing marketing authorizations, variations, renewals, and regulatory submissions to COFEPRIS, reviewing technical documentation, and ensuring timelines. English fluency is required; 1+ year in regulatory affairs preferred. Hybrid work options available.

Qualifications

• Bachelor's degree in pharmaceutical chemistry or related field.
• Proficiency in English and knowledge of COFEPRIS requirements.
• 1+ year of regulatory affairs experience in pharma.

Responsibilities

• Manage regulatory submissions to COFEPRIS and lifecycle activities.
• Review technical and administrative documentation for submissions.
• Coordinate regulatory activities to ensure timelines and compliance.
• Assess deficiencies, implement corrective actions, and liaise with stakeholders.
• Maintain document quality and minimize regulatory observations.

Skills

Regulatory knowledge

Attention to detail

Analytical thinking

Initiative & action

Collaboration

Results oriented

Regulatory compliance

Project planning

Documentation

Education

Bachelor's Degree in Pharmaceutical Chemistry and Biology (QFB)

Job description

Sandoz Mexico City is seeking a Regulatory Affairs professional to maintain portfolio regulatory tasks, coordinate submissions, and ensure product continuity with the authorities.

Responsibilities include managing marketing authorizations, variations, renewals, and regulatory submissions to COFEPRIS, reviewing technical documentation, and ensuring timelines. English fluency is required; 1+ year in regulatory affairs preferred. Hybrid work options available.