Regulatory Affairs Specialist: COFEPRIS Submissions

Sandoz México; Ciudad de México; On-site; MXN 300,000 - 540,000; Full time

Job summary

Sandoz México is seeking a Regulatory Affairs professional to support the regulatory submissions and lifecycle management of medicinal products. You will coordinate with COFEPRIS, ensure timelines, and maintain high-quality documentation to support market authorizations.

Ideal candidates have at least 1 year in Regulatory Affairs, strong attention to detail, and fluency in English to collaborate with global teams across borders.

Qualifications

• Bachelor's Degree in Pharmaceutical Chemistry and Biology (QFB) or related field.
• English language required.
• Minimum 1 year of professional experience in Regulatory Affairs.

Responsibilities

• Regulatory submissions management including variations, renewals, and COFEPRIS submissions.
• Regulatory and compliance oversight for Mexican regulations and health authority requirements.
• Interpretation of technical, scientific, and administrative documentation for regulatory submissions.
• Lifecycle management of marketing authorizations, ensuring compliance with timelines and requirements.
• Identify deficiencies, coordinate corrective actions, and maintain document quality and compliance.

Skills

Responsibility

Analytical Skill

Initiative

Results Oriented

Collaboration

Detail Oriented

Quality & Patient

Project Planning

Regulatory Compliance

Education

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

Job description

Sandoz México is seeking a Regulatory Affairs professional to support the regulatory submissions and lifecycle management of medicinal products. You will coordinate with COFEPRIS, ensure timelines, and maintain high-quality documentation to support market authorizations.

Ideal candidates have at least 1 year in Regulatory Affairs, strong attention to detail, and fluency in English to collaborate with global teams across borders.