Regulatory Affairs Lead – LATAM (Remote, Mexico City)

About the role

We are looking for an experienced Regulatory Affairs Lead for Latin America to build and manage Pharmanovia’s regional regulatory function. Reporting to the Head of Regulatory Affairs, you will act as the primary regulatory expert for the LATAM market, supporting product registrations, lifecycle management and new product launches.

Key responsibilities

• Establish and lead the Regulatory Affairs function across LATAM, aligning with global objectives.
• Develop and execute regulatory strategies for product registrations, variations, renewals and post‑approval activities.
• Manage CTA, CTA exemption, NDA, variation, renewal and post‑approval submissions to obtain market authorisations.
• Serve as the main regulatory liaison with health authorities such as COFEPRIS and other national agencies.
• Provide strategic regulatory input to cross‑functional teams including Commercial, Scientific and Business Development.

Required profile

• Proven experience in regulatory affairs within the pharmaceutical sector in Latin America.
• Strong knowledge of regional health authority requirements and processes.
• Ability to lead a regional team and work closely with global functions.

Required skills

• CTA and CTA exemption management.
• NDA preparation and submission.
• Variation and renewal dossier handling.
• Post‑approval regulatory activities.