PHARMAFull-time
Coordinador de Asuntos Regulatorios
BOGOTÁ (CO)ONSITEPOSTED: 8/10/2026
PHARMAFull-time
HIRING ORGANIZATIONASTRAZENECAPharmaceuticals / Biopharmaceuticals / Healthcare
ROLE DEFINITION & RESPONSIBILITIES
Manage regulatory filings, initial health registrations, renewals, and technical-legal modifications for pharmaceutical products across Colombia, Peru, and Ecuador (Andean Cluster).
Prepare and submit regulatory documentation to INVIMA, DIGEMID, and ARCSA while responding to health authority observations and information requests.
Review and approve artwork, packaging component designs, and promotional materials in compliance with local regulations and corporate standards.
Oversee GxP/GRP compliance, portfolio maintenance, market shortage reporting, and cross-functional collaboration with global and regional regulatory teams.
REQUIRED VERIFIED SKILLS
Regulatory Affairs
INVIMA Regulations
DIGEMID Regulations
ARCSA Regulations
Pharmaceutical Registration
English Proficiency
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
AstraZeneca is a global, science-led biopharmaceutical company focused on the discovery, development, and commercialisation of prescription medicines. The company operates in various therapeutic areas, including Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. AstraZeneca is committed to pushing the boundaries of science to deliver life-changing medicines and improve patient outcomes worldwide.
TEAM SIZE: 89,000+ employees
INDUSTRY: Pharmaceuticals / Biopharmaceuticals / Healthcare
RECOMMENDED TRAINING
1/5
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