Regulatory Affairs Specialist — Hybrid (Biosimilars)

Sandoz México; Ciudad de México; On-site; MXN 300,000 - 520,000; Full time

Job summary

Sandoz México is seeking a Regulatory Affairs professional to lead submissions, variations and renewals with COFEPRIS. You will ensure compliance with Mexican regulations, review technical documentation and coordinate activities across global teams.

The role requires you to manage multiple regulatory tasks with attention to quality, while collaborating with international stakeholders to maintain business continuity.

Qualifications

• Bachelor’s degree in Pharmaceutical Chemistry and Biology (QFB) or related field.
• English language proficiency.
• Minimum of one year of professional experience in regulatory affairs.

Responsibilities

• Regulatory Affairs knowledge in the pharmaceutical industry, managing marketing authorizations, variations, renewals, and submissions to COFEPRIS.
• Regulatory and compliance expertise with Mexican regulations and health authority requirements.
• Review and interpret technical, scientific and administrative documentation to support regulatory submissions.
• Coordinate regulatory activities while ensuring timelines and regulatory requirements.
• Analyze regulatory deficiencies, authority requests and define corrective actions.
• Maintain document quality and regulatory compliance to minimize authority observations.
• Review global documentation and collaborate with international stakeholders.
• Manage multiple regulatory activities concurrently to ensure business continuity.

Skills

Responsibility

Analytical Skill

Initiative & Action

Results Oriented

Collaboration

Detail Oriented

Focus on Quality and 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 lead submissions, variations and renewals with COFEPRIS. You will ensure compliance with Mexican regulations, review technical documentation and coordinate activities across global teams.

The role requires you to manage multiple regulatory tasks with attention to quality, while collaborating with international stakeholders to maintain business continuity.