Regulatory Affairs Lead LATAM - Full-Time - Remote - Based in Mexico City

We are seeking an experienced Regulatory Affairs Lead to oversee regulatory strategy, submissions and compliance activities across Latin America. This role will lead regional regulatory planning, support product registrations and lifecycle management, coordinate interactions with health authorities and provide strategic regulatory guidance to cross-functional teams. The successful candidate will have strong knowledge of pharmaceutical regulations across LATAM, excellent stakeholder management skills and the ability to navigate complex regulatory environments.
Regulatory Affairs Lead - Key responsibilities (LATAM regulatory strategy and submissions)
• Develop and implement regulatory strategies and operating plans for Latin American markets, aligned with general objectives, product priorities and applicable local requirements.

• Lead regional regulatory planning for new product registrations, line extensions, variations, renewals, transfers and other lifecycle management activities.





• Coordinate the preparation, review, submission and maintenance of regulatory dossiers and supporting documentation across LATAM.

• Manage regulatory submissions and approval activities with national health authorities, including ANVISA, COFEPRIS, INVIMA, ISP, DIGEMID and other relevant agencies.

• Provide regulatory input into product development, clinical programmes, labelling, packaging, artwork, promotional materials and market launch planning.

• Monitor changes in pharmaceutical legislation, regulatory guidance, health authority expectations and industry standards across Latin American markets.

• Assess regulatory requirements, risks and opportunities associated with new products, business development activities, market expansion and portfolio changes.

• Prepare clear regulatory assessments, submission plans, briefing documents, responses to authority questions and status reports for internal stakeholde

📌 Regulatory Affairs Lead LATAM (Ciudad de México)
🏢 Pharmanovia
📍 Ciudad de México