The Role As Director of Regulatory Affairs & Quality Assurance, you will serve as the in-country leader shaping Moderna’s regulatory and quality strategy across Mexico. You will operate at the intersection of science, compliance and public health—ensuring timely access to innovative mRNA vaccines and biologics. Here’s 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 and post‑approval commitments; coordinate responses to regulatory queries (RTQs). 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 applicable health authority expectations in Mexico. Lead and manage product defect investigations and recall activities in Mexico, serving as the primary liaison with COFEPRIS and coordinating with global regulatory and quality teams and other health authorities (e.g., FDA, EMA) as applicable. 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. Oversee and support the Quality Management System (QMS), ensuring inspection readiness, state of control and continuous improvement across quality processes, including deviations, investigations, CAPAs, change controls and product complaints. Ensure quality systems, processes, SOPs and agreements are aligned with global quality strategy and meet all applicable regulatory requirements for the development, manufacture, testing, release and distribution of products. Lead monitoring and management review of quality KPIs, ensuring effective risk mitigation and resolution of quality issues. Support regulatory inspections (e.g., GMP, GCP, GVP) and ensure effective preparation and follow‑up. Oversee local distribution quality and supply compliance activities, including risk assessments, subcontractor management, transportation conditions, product integrity and distribution system controls (e.g., contracts, specifications, recalls, returns and stock monitoring). Bring deep expertise in vaccines and biologics, strong knowledge of Mexican regulatory frameworks and the ability to navigate complex and evolving regulatory environments, including reliance pathways and emergency mechanisms. Operate effectively in a fast‑paced, matrixed environment, leading complex regulatory strategies across multiple programs while influencing cross‑functional stakeholders. Apply strong business acumen and communication skills to clearly articulate regulatory strategies, risks and recommendations to senior leadership and external stakeholders. What You’ll Bring To The Table Degree in Life Sciences or related discipline; advanced degree preferred (PharmD, MSc, PhD). 12+ years of experience in the pharmaceutical/biotech industry, including 8+ years in regulatory affairs with demonstrated experience in regulatory strategy for biologics or vaccines. Experience in quality systems and compliance, with strong understanding of cGMP requirements, QMS and regulatory expectations for biologics and vaccines. Deep knowledge of Mexican regulatory frameworks, with proven experience engaging with COFEPRIS and managing regulatory submissions in alignment with global health authorities (e.g., FDA, EMA). Extensive experience with CTD/eCTD submissions and lifecycle management, including major filings and post‑approval changes. Eligibility to serve as Responsable Sanitario in Mexico. Experience supporting commercial product release, including biotech and/or sterile products. Strong understanding of regulatory pathways, including reliance models, priority review and emergency use mechanisms. Ability to lead complex regulatory strategies and manage multiple programs in a fast‑paced, matrixed environment. Strong cross‑functional leadership skills, with the ability to influence stakeholders across Commercial, Medical, Quality and Supply. Exceptional communication skills, with the ability to clearly articulate regulatory strategies, risks and recommendations to senior leadership and external stakeholders. Strong business acumen and understanding of pharmaceutical development, commercialization and quality governance. Fluency in English and Spanish required. Pay & Benefits A holistic approach to well‑being with access to fitness, mindfulness and mental health support. Family building benefits, including fertility, adoption and surrogacy support. Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days and a discretionary year‑end shutdown. Moderna is committed to equal opportunity in employment and non‑discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. #J-18808-Ljbffr