Senior Associate, Regulatory Strategy – Infectious Diseases, Biological Products

• Support the Director, Regulatory Affairs & Quality Assurance, in executing regulatory strategies and priorities for product lifecycle
• Perform initial regulatory impact assessments for proposed global changes and recommend submission requirements, sequencing, dependencies, documentation needs, and timelines
• Identify and assess regulatory risks, issues, dependencies, and potential delays; escalate them with proposed mitigation actions
• Monitor regulatory requirements, COFEPRIS criteria, procedural updates, and emerging practices; provide regulatory intelligence and impact assessments
• Support regulatory procedures before COFEPRIS, including preparation and follow-up of submissions, responses to queries, commitments, and post-approval activities
• Coordinate labeling and artwork regulatory activities, including local prescribing information, packaging components, approved conditions, and safety-related updates
• Maintain an integrated regulatory portfolio covering registrations, submissions, approvals, commitments, renewals, post-approval changes, authority requests, dependencies, and milestones
• Maintain regulatory plans, submission schedules, trackers, and status reports; provide operational updates
• Own assigned regulatory activities end-to-end, driving inputs, timelines, document readiness, follow-up, and closure
• Coordinate regulatory assessments and execution of CMC and manufacturing-related changes
• Collaborate with Global Regulatory CMC, Quality, and Supply Chain teams
• Maintain regulatory records, submissions, approvals, correspondence, and commitments in applicable systems and repositories
• Support local Quality activities, compliance requirements, quality events, inspection readiness, and audit readiness
• Coordinate with Global Regulatory, Regional Regulatory, Medical, Pharmacovigilance, Supply Chain, Quality, Commercial, and other cross-functional partners
• Escalate strategic decisions, material risks, and authority-sensitive matters to the Director

• BA/BS degree in a scientific, engineering, or healthcare discipline
• 5+ years of experience in the pharmaceutical industry, preferably in LATAM countries
• 3+ years of experience in regulatory strategy or relevant training/experience
• Exceptional written and oral communication in English and Spanish
• Strong knowledge of current US and EU regulations
• Strong experience with CTD format and content of regulatory filings
• Knowledge and broad experience with regulatory procedures and legislation for drug development, product registration, line extension, and license maintenance
• Demonstrated strong organizational skills, including the ability to prioritize workload
• Experience in the preparation of regulatory submissions and supportive amendments or supplements
• Experience authoring regulatory documents
• Knowledge and understanding of applicable regulations
• Preferred: Masters, PharmD, or PhD degree
• Preferred: Experience in Infectious Diseases and Biologicals
• Preferred: Experience working on products in development, specifically relating to clinical and pre-clinical regulatory aspects
• Preferred: Experience with regulatory procedures and legislation from both US and EU markets

• No specific benefits, perks, or compensation extras stated