Regulatory Affairs Manager (Bogotá)

Amgen · Bogota, Colombia

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Role summary

Regulatory Affairs Manager position in Bogotá serving as Local Regulatory Representative for Amgen's Colombia operations. Leads regulatory strategy, product lifecycle management, and health authority engagement to ensure timely patient access and compliance with Colombian regulations and INVIMA requirements.

Where this listing comes from

This listing was compiled by RoleLantern from the employer's publicly available posting on Workday, captured and rephrased by RoleLantern using automated (AI) tools on 2026-10-04 (originally posted 2026-10-04). It was not submitted or confirmed by the employer through RoleLantern. Details may be inaccurate, incomplete, outdated, or no longer available; please confirm with the employer's official posting before applying.

What they're looking for

Regulatory affairs experience with health authority interactions and submissions
Knowledge of Colombian pharmaceutical regulations and INVIMA requirements
Strategic planning and lifecycle management expertise for pharmaceutical products
Cross-functional collaboration and stakeholder management skills
Regulatory documentation management and compliance experience
Ability to interpret regulatory changes and communicate business impacts

What you'll be doing

Own regulatory strategy and lifecycle management for assigned product portfolio in Colombia
Lead preparation, submission, and approval of sanitary registrations, modifications, renewals, and labeling updates
Serve as primary regulatory contact with INVIMA and coordinate authority interactions
Assess regulatory risks, define mitigation strategies, and communicate compliance impacts
Partner with global, regional, and local teams on product launches, access initiatives, and business continuity

Privacy & handoff

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