Regulatory Affairs Lead – Mexico

About the role

The Regulatory Affairs Lead will provide strategic direction and leadership for Viatris' product portfolio in Mexico. This role ensures alignment with local regulatory requirements, supports product access, and collaborates with cross‑functional teams to achieve business objectives.

Key responsibilities

• Lead and manage the regulatory affairs (RA) team in developing strategies for new product registrations, generics, line extensions, major variations, and lifecycle management.
• Interface with Commercial, Quality, Medical, and Supply functions to ensure collaborative connectivity and support country and regional business goals.
• Maintain marketing authorizations and licenses in compliance with local regulations, ensuring corporate processes, SOPs, and systems are effective.
• Oversee preparation, submission, and approval of regulatory dossiers according to defined launch plans.
• Establish and maintain strong relationships with local regulatory authorities and participate in trade associations to influence regulatory processes.
• Provide regulatory input to global strategies and ensure alignment with country business and commercial plans.
• Develop, coach, and evaluate direct reports to build a high‑performing RA team.

Required profile

• Proven leadership experience in regulatory affairs within the pharmaceutical or healthcare sector.
• Deep knowledge of Mexican regulatory requirements and processes.
• Strong ability to build relationships with authorities and industry stakeholders.
• Excellent communication and cross‑functional collaboration skills.
• Track record of managing complex regulatory projects and delivering timely approvals.

Required skills