Regulatory Affairs Lead – Mexico

About the role

The Regulatory Affairs Lead will provide strategic direction and leadership for Viatris' portfolio in Mexico. This role ensures seamless collaboration with commercial, quality, medical, and supply functions to support business objectives and product access across the country.

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.
• Provide strategic regulatory input to global strategies, aligning them with local business goals.
• Maintain marketing authorizations and licenses in compliance with Mexican regulations, ensuring SOPs, systems, and staff training are up‑to‑date.
• Oversee the preparation, submission, and approval of regulatory dossiers according to launch plans.
• Ensure all RA activities comply with local regulatory requirements and best practices.
• Collaborate with internal stakeholders on registration and variation submissions, aligning regulatory actions with commercial and manufacturing plans.
• Develop, lead, and performance‑manage direct reports, fostering team capability through training and development.
• Establish and nurture relationships with local regulatory authorities and participate in trade associations to influence regulatory processes.

Required profile

• Proven leadership experience in regulatory affairs within the pharmaceutical or healthcare sector.
• Strong strategic thinking and ability to align regulatory activities with business objectives.
• Excellent communication skills for interfacing with internal functions and external authorities.
• Track record of managing teams and driving performance improvements.

Required skills

What we offer

• Opportunity to shape regulatory strategy for a global healthcare company.
• Collaborative environment with cross‑functional teams.
• Professional development and leadership growth.