Regional Director Regulatory Affairs

About the role

We are seeking a Regional Director of Regulatory Affairs to lead and coordinate regulatory strategy across Latin America. The role serves as the primary interface between global, regional and local regulatory teams, ensuring efficient submissions, approvals and lifecycle management for our pharmaceutical portfolio.

Key responsibilities

• Provide strategic oversight to local Regulatory Affairs teams, ensuring alignment with corporate objectives and global standards.
• Act as the main liaison between Global RA and LATAM countries, coordinating with Clinical, Medical, PV, Supply and Quality functions.
• Guide affiliates on submissions, regulatory maintenance and product lifecycle activities, and serve as escalation point for complex matters.
• Monitor submission progress, approval timelines and support acceleration strategies such as reliance pathways.
• Review regulatory assumptions impacting costs, align regulatory plans with budget forecasts, and oversee portfolio and budget oversight.
• Identify regulatory risks, develop mitigation strategies and track competitor and intelligence activities.
• Establish and monitor KPIs for regulatory lifecycle activities, ensuring data integrity in regulatory systems and databases.

Required profile

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Biotechnology or related scientific discipline.
• 5–8 years of experience in Regulatory Affairs within the pharmaceutical or biopharmaceutical industry.
• Proven experience in regulatory lifecycle management, including submissions, renewals and post‑approval changes.
• Strong knowledge of Latin American regulatory requirements (e.g., COFEPRIS, ANVISA) and international standards (ICH, FDA, EMA).
• Master’s degree or higher in Regulatory Affairs or Pharmaceutical Sciences is desirable.

Required skills

• Regulatory lifecycle management
• Regulatory submissions and renewals
• Regulatory intelligence and risk mitigation
• Knowledge of ICH, FDA, EMA guidelines
• Familiarity with COFEPRIS and ANVISA regulations
• Use of regulatory systems and databases