Senior Associate Regulatory Affairs - Clinical Studies (CDMX)

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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 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.

Senior Associate Regulatory Affairs - Clinical Studies (CDMX)

The Local Senior Associate Regulatory Affairs provides high-level regulatory leadership for Amgen-sponsored clinical studies in Mexico. The role independently drives local regulatory strategy, decision-making, and execution to ensure timely, compliant clinical trial authorizations and lifecycle management in a sophisticated and evolving regulatory environment. The position serves as the primary local regulatory collaboration with Health Authorities and Ethics Committees acquired by GSO and acts as a strategic partner to global Cross functional teams.

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What you will do

Key responsibilities include, but are not limited to:

• Independently handle and maintain complete, accurate, and traceable regulatory documentation supporting clinical protocol approvals for initial and lifecycle management protocols submitted via DIGIPRiS, in compliance with NOM-012-SSA3-2012, applicable COFEPRIS regulations, and Amgen policies.
• Document and implement local regulatory strategies based on current health legislation, COFEPRIS guidelines, and formal regulatory agreements, ensuring alignment with approved submission pathways.
• Ensure consistency application of Good Clinical Practice (GCP) requirements across regulatory submissions and Health Authority communications.
• Systematically assess, document, and mitigate regulatory risks, including communication and escalation within Local Study Teams (LSTs) and relevant governance forums.
• Maintain detailed collaboration with Global Regulatory, Clinical Operations, Quality, Safety, Medical, and Legal functions to support regulatory compliance and inspection readiness.
• Define and implement local regulatory strategies based on health legislation expertise and interpretation of COFEPRIS guidelines, agreements, and evolving regulatory criteria.
• Independently assess regulatory risks and determine appropriate submission pathways and documentation approaches to support timely protocol approvals.
• Proactively assess, communicate, and mitigate regulatory risks impacting timelines and compliance during the internal LST (Local Study Team).
• Collaborating with Global Regulatory, Clinical Operations, Quality, Safety, Medical, and Legal partners
• Apply regulatory and ethical requirements, including CONBIOÉTICA guidelines, to support compliance with local Ethics Committee expectations for protocol, Inform Consent Form and other subject material or information.
• Lead the preparation and coordination of responses to Health Authority deficiency letters, prevention notices, and clarification requests, ensuring accuracy, consistency, and strategic alignment.
• Maintain inspection readiness and regulatory traceability within RIM systems.
• Coordinate and lead all aspects of all documentation elements required for submission under the Unified Formats, in accordance with the Administrative Simplification Agreement (April 28, 2025).
• Ensure end-to-end regulatory submission readiness, including alignment with internal team members and submission timelines.
• Review internal area for quality control and identify gaps solving them and for training purposes.

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:

• Master’s degree in health sciences or related field and experience in Clinical Regulatory Affairs in Mexico in similar positions on a big pharmaceutical company
• Bachelor’s degree in health sciences or related field and 2 years of experience in Clinical Regulatory Affairs in Mexico in similar positions on a big pharmaceutical company Or
• Associate’s degree in health sciences or related field and 6 years of experience in Clinical Regulatory Affairs in Mexico in similar positions on a big pharmaceutical company Or
• Proficiency in English, both in oral and written communication.

Preferred Qualifications:

• Digipris domain for submission execution and training purposes.
• Regulatory Affairs and/or GCP certification.
• Proven experience handling regulatory complexity and high-impact regulatory decisions.
• Work in teams and cross functional previous experience.
• High proficiency in internal and external communication.

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.

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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.