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, global 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.
- Oversee and support the Quality Management System (QMS), ensuring inspection readiness, control status, 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 development, manufacture, testing, release, and distribution of products.
- Lead monitoring and management review of quality KPIs, ensuring 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 (contracts, specifications, recalls, returns, and stock monitoring).
- Apply 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 articulate regulatory strategies, risks, and recommendations to senior leadership and external stakeholders. Qualifications
- 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 a 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 integral 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. 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.
- Competitive compensation and performance‑based incentives.
- Comprehensive medical, dental, vision, and life insurance.
- Retirement savings plan with company match.
- Employee assistance and financial counseling programs.
- Opportunities for professional development and career advancement. Equal Opportunity Statement 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 personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Moderna is a smoke‑free, alcohol‑free, and drug‑free work environment. #J-18808-Ljbffr Postúlate en Kit Empleo: kitempleo.com.mx/empleo/5uxsfh