Regulatory Affairs Manager  (Bogotá)

Career Category Regulatory Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on patients’ lives as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives. Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lie within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Regulatory Affairs Manager (Bogotá ) The Regulatory Affairs Manager for Colombia, serving as the Local Regulatory Representative (LRR), is accountable for leading and executing local regulatory strategies that enable timely patient access and effective lifecycle management of Amgen products in Colombia. The role leads the planning, preparation, submission, tracking, and approval of new sanitary registrations and marketing authorizations, post-approval modifications, renewals or other maintenance activities where applicable, indication extensions, labeling updates, and related regulatory activities, in compliance with Colombian regulations, INVIMA requirements, and Amgen policies and standards. The LRR serves as a key regulatory advisor and the primary local interface with INVIMA and other relevant Colombian authorities and stakeholders. The role proactively identifies regulatory risks, defines mitigation plans, and partners with Global, Regional, and cross-functional teams to support business priorities, maintain compliant product supply, and protect patient access. What you will do Let’s do this. Let’s change the world. In this vital role you will: Own regulatory strategy and product lifecycle management for the assigned portfolio in Colombia. Lead the development and execution of evidence-based local regulatory strategies and filing plans for assigned products throughout their lifecycle in Colombia. Ensure timely preparation, submission, follow-up, and approval of new sanitary registrations, post-approval modifications, renewals or maintenance activities where applicable, indication extensions, administrative changes, and labeling updates. Provide strategic Colombian regulatory input to Global and Regional Regulatory teams to optimize development, registration, launch, access, and lifecycle-management plans. Assess regulatory risks and opportunities, define mitigation strategies, and clearly communicate potential business, supply, compliance, and patient-access impacts. Ensure local implementation of approved labeling changes, including prescribing information, instructions for use, labels, package inserts, patient leaflets, cartons, and other artwork components, in coordination with relevant functions. Lead or support regulatory assessments related to product supply, manufacturing-site and quality changes, importation requirements, certificates, and other documentation needed to maintain compliant supply in Colombia. Health Authority and External Engagement Act as the primary regulatory contact with INVIMA for assigned products and regulatory activities, and engage the Ministry of Health and Social Protection or other authorities when relevant. Lead and coordinate regulatory meetings, responses to information requests, deficiency letters, technical clarifications, and other interactions with Colombian health authorities. Build and maintain effective professional relationships with relevant INVIMA and external stakeholders while ensuring full compliance with applicable laws and Amgen policies. Monitor and interpret changes in Colombian legislation, regulations, technical standards, guidance, and health-authority practices; translate them into clear business implications, risks, impacts, and recommendations. Cross-Functional Partnership and Compliance Partner closely with Global, Regional, and Local Regulatory, Quality, Safety, Medical, Clinical Development, Supply Chain, Access, Legal, Healthcare Compliance, and Commercial teams to assure business continuity. Provide timely regulatory guidance to support product launches, reimbursement and access initiatives, clinical trial activities, medical and commercial communications, and business continuity in Colombia. Ensure regulatory review of promotional and non-promotional materials, as applicable, in accordance with Colombian requirements, relevant industry codes, and Amgen procedures. Contribute to the local compliance framework by identifying regulatory obligations and supporting the implementation of necessary controls. Ensure accurate and inspection-ready maintenance of regulatory documentation, submission records, tracking tools, commitments, licenses, and local regulatory intelligence. Operational Excellence and People Leadership Drive continuous improvement of regulatory processes, systems, and ways of working, including leadership of the Regulatory Information Management (RIM) function, to strengthen predictability, submission quality, compliance, and efficiency. Manage external regulatory consultants, service providers, and contractors, where applicable. Lead, coach, and share knowledge with peers and cross-functional partners, fostering accountability, collaboration, and high-quality execution. Establish clear priorities and ensure appropriate resource allocation across the portfolio.