Regulatory Affairs Manager (Bogotá)

About the role

The Regulatory Affairs Manager for Colombia serves as the Local Regulatory Representative (LRR) and is responsible for leading and executing local regulatory strategies to ensure timely patient access and effective lifecycle management of Amgen products in Colombia.

Key responsibilities

• Own regulatory strategy and product lifecycle management for the assigned portfolio in Colombia, including preparation, submission, and approval of registrations, modifications, renewals, and labeling updates.
• Act as the primary regulatory contact with INVIMA and other Colombian authorities, leading meetings, responding to information requests, and maintaining professional relationships.
• Partner with Global, Regional, and cross‑functional teams to support product launches, access initiatives, clinical trials, and ensure compliance of promotional materials.
• Drive continuous improvement of regulatory processes, manage external consultants, and lead the Regulatory Information Management function.

Required profile

• Professional degree in Pharmacy or related scientific discipline.
• At least 7 years of Regulatory Affairs experience in pharma/biotech, with minimum 2 years managing regulatory submissions and product lifecycle activities.
• Strong knowledge of Colombian pharmaceutical legislation, INVIMA processes, and requirements for innovative medicines, biologics, biosimilars, and small molecules.
• Fluency in Spanish and professional proficiency in English.

Required skills

• Expertise in Colombian regulatory requirements and INVIMA procedures.
• Ability to assess regulatory risks, develop mitigation strategies, and communicate impacts to senior stakeholders.
• Strong strategic thinking, problem‑solving, and decision‑making abilities.
• Proficiency with regulatory information management systems and digital tools for data analytics.