When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Sr. Associate, Regulatory Strategy (Infectious Diseases and Biological Products) Work location and arrangement: Mexico City - Hybrid
We are seeking a Sr. Associate, Regulatory Strategy with strong experience in regulatory affairs, dossier management, registration applications, and interactions with LATAM Health Authorities. In this role, you will provide comprehensive regulatory support to the Director, Regulatory Affairs & Quality Assurance, with a focus on COFEPRIS interactions and product lifecycle management.
About the Role This position offers the opportunity to drive regulatory strategy and execution for product programs in the LATAM region. You will work independently on assigned deliverables while collaborating closely with global and regional partners to ensure timely, compliant submissions and approvals.
Key Responsibilities Regulatory Strategy & Planning Support the Director, Regulatory Affairs & Quality Assurance in the execution of regulatory strategies and priorities for product lifecycle
Perform initial regulatory impact assessments for proposed general changes and provide recommendations on submission requirements, sequencing, dependencies, documentation needs, and anticipated timelines
Identify and assess regulatory risks, issues, dependencies,



and potential delays for assigned activities, and escalat...
Monitor regulatory requirements, COFEPRIS criteria, procedural updates, and emerging practices; provide concise regulatory intelligence and impact assessments
Submissions & Authority Management Demonstrate hands-on experience supporting regulatory procedures before COFEPRIS, including preparation and follow-up submissions, responses to queries, commitments, and post-approval activities
Coordinate labeling and artwork regulatory activities, including review of local prescribing information and packaging components, alignment with approved conditions, and implementation of safety-related updates
Maintain an integrated regulatory portfolio view, including registrations, submissions, approvals, commitments, renewals, post-approval changes, authority requests, key dependencies, and upcoming milestones
Maintain accurate regulatory plans, submission schedules, trackers, and status reports; provide clear operational updates to the Director and relevant stakeholders
Own assigned regulatory activities end-to-end, proactively driving inputs, timelines, document readiness, follow-up, and closure
CMC & Post-Approval Changes Coordinate regulatory assessments and execution of CMC and manufacturing-related changes, including manufacturing sites, specifications, processes, analytical methods, packaging, and other post-approval changes




Collaborate closely with Global Regulatory CMC, Quality, and Supply Chain teams to ensure alignment and timely execution
Documentation & Compliance Ensure regulatory records, submissions, approvals, correspondence, and commitments are appropriately documented and maintained in applicable Moderna regulatory systems and repositories
Support the Director in the execution and follow-up of local Quality activities, priorities, and compliance requirements
Support the management, documentation, and follow-up of quality events, including deviations, CAPAs, change controls, complaints, and other quality-related actions
Support inspection and audit readiness activities, including preparation and organization of documentation, tracking of requests and observations, and follow-up of agreed actions
Cross-Functional Collaboration Coordinate with Global Regulatory, Regional Regulatory, Medical, Pharmacovigilance, Supply Chain, Quality, Commercial, and other cross-functional partners to obtain inputs and maintain delivery timelines
Escalate strategic decisions, material risks, and authority-sensitive matters to the Director as appropriate
Required Qualifications 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 extensi

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📌 Sr. Associate, Regulatory Strategy (Infectious Diseases and Biological Products) (Nezahualcóyotl)
🏢 Parexel
📍 Nezahualcóyotl