Regulatory Affairs Specialist

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 global 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 CMC in agreed timeline -Adherence to Sandoz policy and guidelines
• Application forms, labeling and other documents prepared in accordance with regulations and working procedure within established timelines.
• Submissions without critical observations due to deficiencies on the internal review.

• Administrative tasks completed on time according to local and global procedures

• Databases updated on time and with the appropriate quality

Minimum Requirements:

• Education: Bachelor’s Degree in Pharmaceutical Chemistry and Biology (QFB) or a related field.
• Language: English.
• Required Experience: Minimum of one year of professional experience in the pharmaceutical industry, specifically in Regulatory Affairs.
  

Skills:

• Responsibility
• Analytical Skill.
• Initiative & Action
• Results Oriented
• Collaboration.
• Detail Oriented.
• Focus on Quality and Patient
• Project Planning.
• Regulatory Compliance.
  

Languages :

• English.

Why Sandoz?

Generic and biosimilar medicines are the backbone of the global pharmaceutical industry. Sandoz, a leader in this sector, provided more than 900 million treatments to patients in over 100 countries in 2024. Through investments in new development capabilities, production facilities, acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients access high-quality, affordable medicines in a sustainable way. Our open and collaborative culture is powered by talented and ambitious colleagues in an agile and collegial environment with impactful, flexible, and hybrid careers—where diversity is welcomed and personal growth is supported.

Commitment To Diversity And Inclusion

We are committed to creating an exceptional and inclusive work environment and diverse teams that represent the patients and communities we serve.

Skills Desired

Analytical Skill, Clinical Trials, Collaboration, Detail-Oriented, Lifesciences, Project Planning, Regulatory Compliance