Colombia Regulatory Affairs Lead — Strategic Access

Amgen

Bogotá ciudad

On-site

COP 191,113,000 - 286,670,000

Full time

4 days ago

Be an early applicant

A complete application in a minute

Tailored resume and cover letter, ready to send.

Get past ATS filters

Job summary

Amgen seeks a Regulatory Affairs Manager for Colombia to lead local regulatory strategies and lifecycle management, serving as the local interface with INVIMA and other authorities. You will coordinate cross‑functional teams to ensure timely registrations, labeling updates, and compliance while supporting product access and lifecycle management.

The role requires a professional degree in Pharmacy with 7+ years in Regulatory Affairs, fluency in Spanish and English, and strong leadership and

Qualifications

Professional degree in Pharmacy, or a related scientific discipline, plus at least 7 years of Regulatory Affairs experience in the pharmaceutical or biotechnology industry (at least 2 years directly managing regulatory submissions).
Fluency in Spanish and professional proficiency in English, with strong written and verbal communication skills.

Responsibilities

Own regulatory strategy and product lifecycle management for the assigned portfolio in Colombia.
Lead development and execution of local regulatory strategies and filing plans for assigned products.
Ensure timely preparation, submission, follow‑up, and approval of submissions and labeling updates.
Provide strategic Colombian regulatory input to Global and Regional teams to optimize plans.
Assess regulatory risks and communicate impacts to stakeholders.
Coordinate labeling changes with relevant functions across the organization.
Lead regulatory assessments related to product supply and documentation.