Director, Regulatory Affairs & Quality Assurance - Mexico …, Ciudad Madero

What You’ll Do Lead the development and execution of regulatory strategies for Moderna’s vaccine and biologics portfolio in Mexico, ensuring alignment with regional and global frameworks and successful delivery of submissions and lifecycle management activities across all programs. Serve as the primary regulatory representative with COFEPRIS, leading strategic authority engagement, including scientific advice, dossier discussions, and assessment of regulatory pathways (e.g., full review, reliance mechanisms, priority reviews, and emergency authorizations). Oversee the preparation, submission, and lifecycle management of regulatory dossiers in CTD/eCTD format, including marketing authorizations, CMC variations, renewals, labeling updates, safety updates, post‑approval commitments, and responses to regulatory queries. Ensure compliance with all applicable Mexican regulatory requirements for biologics and vaccines, including oversight of GMP certifications, CPPs, site variations, import licenses, and post‑marketing obligations. Act as the legally appointed Responsable Sanitario, ensuring compliance with regulatory requirements, license conditions, and health‑authority expectations in Mexico. Lead and manage product defect investigations and recall activities in Mexico, coordinating with COFEPRIS, integral regulatory, and quality teams, and with other health authorities (e.g., FDA, EMA). Partner cross‑functionally with Commercial, Medical, Market Access, Supply, and Quality to align regulatory strategies with business objectives, ensuring timely approvals, supply continuity, and successful product lifecycle management. Provide clear communication of regulatory strategies, risks, timelines, and mitigation plans to senior leadership and key stakeholders. Lead regulatory intelligence and policy monitoring in Mexico, proactively assessing changes in healthcare regulations, biologics frameworks, and public health policies, and translating insights into actionable strategies. Postúlate en Kit Empleo: kitempleo.com.mx/empleo/5v1jjy