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

Parexel; Ciudad de México; Hybrid; MXN 600,000 - 1,000,000; Full time

Job summary

Parexel is seeking a Sr. Associate, Regulatory Strategy with LATAM experience to drive submissions, lifecycle management, and COFEPRIS interactions. You will work with the Director and cross-functional teams to ensure timely, compliant regulatory outcomes across the region.

This role emphasizes strategic planning, risk assessment, and collaboration with global partners to support product programs in LATAM. Hybrid work location: Mexico City.

Qualifications

• BA/BS in a scientific, engineering, or healthcare discipline.
• 5+ years in the pharmaceutical industry, preferably LATAM.
• 3+ years in regulatory strategy or related training/experience.
• Excellent written and spoken English and Spanish.
• Strong knowledge of US and EU regulations and CTD format.

Responsibilities

• Support COFEPRIS submissions and follow-up.
• Coordinate labeling and packaging regulatory activities.
• Maintain an integrated regulatory portfolio with registrations, submissions, and milestones.
• Provide regulatory intelligence and impact assessments for changes.
• Own end-to-end regulatory activities and ensure timelines are met.

Skills

Regulatory strategy

LATAM regulatory affairs

Regulatory submissions

Bilingual (English/Spanish)

Regulatory intelligence

Education

BA/BS in science/engineering/healthcare

Job description

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 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 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