Regulatory Affairs Manager (CDMX)

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 the lives of patients 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 lay within them, you’ll thrive as part of the Amgen team. We have proudly achieved certifications as Great Place to Work and Equidad MX. Join us and transform the lives of patients while transforming your career.

The Local Regulatory Representative (LRR), Manager Mexico, is accountable for leading and executing local regulatory strategies that enable timely patient access and lifecycle management of Amgen products in Mexico.

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.

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Biotechnology, or a related scientific discipline and 7 years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry
• Proficiency in English, both in oral and written communication.

• Minimum of 3 years of experience managing regulatory submissions and product lifecycle activities in Mexico.
• Demonstrated experience with COFEPRIS interactions and registration of biologics, biosimilars, innovative medicines, and/or complex post-approval changes.
• Strong knowledge of Mexican pharmaceutical legislation, COFEPRIS processes, and regulatory requirements for innovative products, biotechnological, biosimilars, and small molecules.
• Demonstrated experience in new marketing authorizations and post-approval lifecycle management, including complex technical, safety labeling, and administrative variations.
• Strong understanding of labeling development and implementation requirements in Mexico.
• Proven ability to lead Health Authority interactions, manage complex regulatory issues, and negotiate practical 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 stakeholder-management, written and verbal communication, and cross-functional collaboration skills.

Let’s do this. Let’s change the world. In this vital role you will:

• →Regulatory Strategy and Product Lifecycle Management.
• →Lead the development and execution of local regulatory strategies and filing plans for assigned products throughout their lifecycle.
• →Ensure timely submission, follow-up, and approval of new marketing authorizations, variations, renewals, extensions, administrative changes, and labeling updates.
• →Provide strategic local regulatory input to Global and Regional Regulatory teams to optimize development, registration, launch, and lifecycle-management plans.
• →Assess regulatory risks, define mitigation strategies, and clearly communicate potential business, supply, and patient-access impacts.
• →Ensure local implementation of approved labeling changes, including Prescribing Information, Instructions for Use, cartons, leaflets, and other artwork components, in coordination with relevant functions.
• →Support regulatory assessments related to product supply, manufacturing-site changes, quality-related changes, and importation requirements, as applicable.

• Act as the primary regulatory contact with COFEPRIS for assigned products and regulatory activities.
• Lead and coordinate regulatory meetings, responses to requests for information, technical clarifications, and other interactions with the Health Authority.
• Build and maintain effective professional relationships with relevant COFEPRIS stakeholders, while ensuring full compliance with Amgen policies.
• Monitor and interpret changes in Mexican legislation, regulations, guidelines, and Health Authority practices; translate these into clear business implications risk, impacts and recommendations.

• Partner closely with Global and Regional Regulatory, Quality, Safety, Medical, Clinical Development, Supply Chain, Access, Legal, Healthcare Compliance, and Commercial teams.
• Provide timely regulatory guidance to support product launches, reimbursement and access initiatives, clinical trial activities, communications, and business continuity.
• Ensure regulatory review of promotional and non-promotional materials, as applicable, in accordance with Mexican requirements, pharma associations codes, and Amgen procedures.
• Contribute to the local compliance framework by identifying regulatory obligations and supporting the implementation of necessary controls.
• Ensure accurate maintenance of regulatory documentation, tracking tools, and local regulatory intelligence.

• Drive continuous improvement of regulatory processes, systems, and ways of working to improve predictability, quality, and efficiency.
• Manage external regulatory consultants, service providers, and contractors, where applicable.
• Lead, coach, and share knowledge with peers or cross-functional partners; fostering accountability, collaboration, and high-quality execution.
• Establish clear priorities and ensure appropriate resource allocation across the portfolio.

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.

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.