Daniel Castellanos Orozco
@danielcastellanosoro
I lead LATAM regulatory strategies that accelerate compliant pharmaceutical and medical device market access.
What I'm looking for
At Opella Healthcare, I lead Regulatory Intelligence & Strategy for LATAM Partner Markets, shaping registration, lifecycle, commercialization, and risk-mitigation strategies across complex markets.
Previously, at Freyr Life Sciences, Bayer, Johnson & Johnson MedTech, and Pfizer, I managed regulatory portfolios for pharmaceuticals, OTC products, medical devices, and clinical trial products across Latin America. I've led registrations, renewals, variations, labeling, post-approval compliance, and regulatory submissions while partnering with Quality, Medical, Marketing, Commercial, and global teams to support launches and continuity of supply.
I'm a Pharmaceutical Chemist who brings regulatory intelligence, automation, process standardization, and strong relationships with health authorities to improve traceability, reduce rework, and accelerate approvals.
Experience
Work history, roles, and key accomplishments
Latam Partner Market Regulatory Lead
Opella Healthcare Latin America
Jan 2026 - Present (7 months)
Led regulatory intelligence and strategy for LATAM partner markets, ensuring compliance and supporting product registration and lifecycle management. Provided strategic guidance to cross-functional teams and built relationships with health authorities.
Education
Degrees, certifications, and relevant coursework
El Bosque University
Postgraduate Diploma, Regulatory Affairs
2024 -
Completed a Postgraduate Diploma in Regulatory Affairs of Synthetic Drugs and Biological Products, specializing in regulatory frameworks for pharmaceutical products.
Universidad Nacional de Colombia
Bachelor's Degree, Pharmaceutical Chemistry
2013 - 2019
Earned a degree in Pharmaceutical Chemistry, gaining comprehensive knowledge in pharmaceutical sciences and regulatory affairs.
Tech stack
Software and tools used professionally
Availability
Location
Authorized to work in
Job categories
Skills
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