Job Description Summary
Ensure the timely regulatory maintenance of the assigned portfolio through effective planning and management of regulatory submissions, proactively identifying and mitigating regulatory risks to support the successful approval of submissions and ensure product continuity in the market without regulatory-related disruptions.

Job Description
Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable biosimilar and generic medicines. As we move forward on this new and ambitious path, unique opportunities will arise, both professionally and personally. Join us—the future is in our hands

Major accountabilities:

• Regulatory Affairs Knowledge in the Pharmaceutical Industry: Experience managing marketing authorizations, variations, renewals, and regulatory submissions to COFEPRIS.
• Regulatory and Compliance Expertise: Strong understanding of Mexican pharmaceutical regulations and health authority requirements.
• Technical and Scientific Assessment: Ability to review and interpret technical,



scientific, and administrative documentation to support regulatory submissions.
• Marketing Authorization Lifecycle Management: Capability to coordinate regulatory activities while ensuring compliance with timelines and regulatory requirements.
• Analytical Thinking and Problem Solving: Ability to assess regulatory deficiencies, authority requests, and define effective corrective actions.
• Attention to Detail and Compliance Focus: Strong commitment to document quality and regulatory compliance to minimize authority observations.
• English Communication Skills: Ability to review integral documentation and collaborate effectively with international stakeholders.
• Prioritization and Sense of Urgency: Ability to manage multiple regulatory activities simultaneously while ensuring business continuity.

Key performance indicators:
• Project & stakeholder feedback -Product license update in terms of

📌 Regulatory Affairs Specialist (Ciudad de México)
🏢 Sandoz
📍 Ciudad de México