Randy Bowen

About Randy Bowen

I am a US-based ECFMG-certified physician with 13+ years of leadership experience across Medical Affairs, Medical Strategy, Scientific Governance, Regulatory Strategy, and Product Lifecycle Management within pharmaceutical and diagnostics organizations. My work spans North America, LATAM, and global markets, supporting complex portfolios from early strategy through launch readiness and lifecycle optimization.

Experience

1. Global Partner Markets Team Lead Latam Medical & Regulatory Affairs Director

   Opella

   Apr 2025 — Present · US

   Company became independent from Sanofi in April 2025; position and responsibilities remained the same.At Opella, I lead the medical and regulatory strategy for our global distributor markets across LATAM, ensuring our operations align with international and local regulations while managing risks effectively.Providing clear guidance to our distributors and local agents to keep processes moving efficiently, I oversee regulatory submissions, renewals, and database management.A key part of my role is leading medical governance, ensuring that all medical activities and responses are scientifically accurate and follow policy standards.I work closely with regulatory agencies and business partners to support product commercialization while maintaining compliance across our markets.Key achievements:• Rolled out targeted training programs to prepare stakeholders for evolving medical and regulatory requirements, strengthening readiness across our teams.• Acted as the central link between regulatory, medical, and commercial teams, ensuring clear communication and smooth cross-functional collaboration to drive projects forward.

Education

• Universidad de Panamá

  Doctor in Medicine (M.D.), Medicine

• Aden Business School

  Master of Business Administration (MBA), Marketing, Management, Strategic Direction, Business Administration

  2015 — 2017

• King's College London

  Medical Affairs in Medicines Development, Healthcare