Sr. Associate, Regulatory Strategy (Infectious Diseases and Biological Products)

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 global 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 escalate them to the Director with proposed mitigation actions

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 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 Qualifications

Masters, PharmD, or PhD degree

Experience in Infectious Diseases and Biologicals

Experience working on products in development, specifically relating to clinical and pre-clinical regulatory aspects

Experience with regulatory procedures and legislation from both US and EU markets

Parexel is a leading clinical research organization (CRO) providing comprehensive drug development and commercialization services to the pharmaceutical and biotech industries. We partner with innovative companies to bring life-changing therapies to patients worldwide. This position is being filled through our recruitment partnership services.