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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek is a type of person with these qualifications.

Basic 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 and product lifecycle activities -with minimum or no supervision).
• Strong knowledge of Colombian pharmaceutical legislation, INVIMA processes, and regulatory requirements for innovative medicines, biological products, biosimilars, and small molecules, including (but not limited to) new drug applications, post-approval variations, labeling and packaging, promotional compliance
• Fluency in Spanish and professional proficiency in English, with strong written and verbal communication skills.

Preferred Qualifications:

• Proven record engaging with INVIMA through the life cycle activities of biologics, biosimilars, and/or small molecules, from GMP certification through obtention, maintenance and surveillance of marketing authorizations.
• Proven ability to lead external engagement (with health authorities, trade associations and other key stakeholders), manage complex regulatory issues, set and negotiate suitable solutions.
• Strategic thinking with strong risk-assessment, problem-solving, prioritization, and decision-making skills.
• Ability to translate complex scientific, technical, and regulatory information into clear and actionable recommendations for senior stakeholders.
• Strong business acumen, written and verbal communication, and cross-functional collaboration skills.
• Forward-looking mindset, with the ability to lead regulatory and competitive intelligence, anticipate emerging trends, and translate insights into proactive strategies and actions.
• Strong digital skills, including data analytics, regulatory information management systems, collaboration tools, and emerging technologies to improve regulatory efficiency and decision-making.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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About Us

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen