LATAM Regulatory Lead — Remote, Shape Market Access

Pharmanovia; Ciudad de México; Hybrid; MXN 1,121,000 - 2,055,000; Full time

Benefits offered by this job

Remote work option

Competitive compensation

Job summary

Pharmanovia, a dynamic pharmaceutical company, seeks a Regulatory Affairs Lead LATAM based in Mexico City or remote. You will establish regional regulatory function and drive strategies for registrations, lifecycle, and market access across LATAM, coordinating with global teams.

You will lead submissions, liaise with COFEPRIS and other authorities, and guide cross-functional teams to ensure compliant, timely product launches and ongoing regulatory excellence across the region.

Qualifications

• Master's degree or higher in a relevant field; minimum 5 years Regulatory Affairs experience.
• Experience developing and executing LATAM regulatory strategies and submissions.
• Proven ability to manage lifecycle activities, registrations, variations and post-approval work.

Responsibilities

• Lead LATAM regulatory affairs function and align with global objectives.
• Develop and execute regulatory strategies for registrations and lifecycle management.
• Manage CTA, NDA, variations, renewals, and post-approval submissions.
• Represent LATAM in regulatory interactions with authorities like COFEPRIS.
• Collaborate with cross-functional teams for launches and market access.

Skills

CTA strategy

NDA/CTA submissions

COFEPRIS knowledge

Regulatory leadership

Regulatory submissions

Bilingual English/Spanish

Cross-functional collaboration

Education

Master's degree

Tools

MS Office

Job description

Pharmanovia, a dynamic pharmaceutical company, seeks a Regulatory Affairs Lead LATAM based in Mexico City or remote. You will establish regional regulatory function and drive strategies for registrations, lifecycle, and market access across LATAM, coordinating with global teams.

You will lead submissions, liaise with COFEPRIS and other authorities, and guide cross-functional teams to ensure compliant, timely product launches and ongoing regulatory excellence across the region.