Senior Associate Regulatory Affairs - Clinical Studies

• 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

• 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
• 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
• Proficiency in English, both in oral and written communication

• 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

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards