Senior Regulatory Strategy – LATAM Infectious Diseases (Hybrid)

Parexel; Ciudad de México; Hybrid; MXN 600,000 - 900,000; Full time

Job summary

Parexel in Mexico City is seeking a Sr. Associate, Regulatory Strategy to drive regulatory planning and submissions for Infectious Diseases and Biological Products in LATAM.

You will work with the Director, Regulatory Affairs & Quality Assurance and cross-functional partners to ensure timely COFEPRIS filings, approvals, and post-approval changes, while maintaining an integrated regulatory portfolio. The role requires 5+ years in pharma regulatory strategy, bilingual English/Spanish, CTD

Qualifications

• BA/BS degree in a scientific, engineering, or healthcare discipline.
• 5+ years in pharma, LATAM preferred.
• 3+ years in regulatory strategy or related experience.
• Exceptional written and oral communication in English and Spanish.
• Strong knowledge of current US and EU regulations.
• Strong experience with CTD format and regulatory filings.
• Knowledge of regulatory procedures and legislation for drug development and license maintenance.
• Demonstrated strong organizational skills.
• Experience in preparation of regulatory submissions and supporting amendments.
• Experience authoring regulatory documents.
• Knowledge of applicable regulations.

Responsibilities

• Support regulatory strategy and priorities for product lifecycle in LATAM.
• Perform regulatory impact assessments and advise submission needs and timelines.
• Identify risks and mitigation actions; escalate to the Director.
• Monitor COFEPRIS rules and provide regulatory intelligence.
• Prepare and follow up COFEPRIS submissions; respond to queries.
• Coordinate labeling and artwork regulatory with local prescribing information.
• Maintain integrated regulatory portfolio with registrations, milestones, and commitments.
• Maintain submission trackers and provide status updates to stakeholders.
• Own assigned activities end-to-end with timelines and closure.
• Coordinate with Global Regulatory CMC, Quality, and Supply Chain teams.
• Support quality events, deviations, CAPAs, and audit readiness.
• Assist in inspections and documentation organization.

Skills

Regulatory strategy

Dossier management

Regulatory submissions

Cross-functional collaboration

Bilingual English/Spanish

Education

BA/BS in science/engineering/healthcare

Masters/PhD preferred

Tools

CTD format knowledge

Job description

Parexel in Mexico City is seeking a Sr. Associate, Regulatory Strategy to drive regulatory planning and submissions for Infectious Diseases and Biological Products in LATAM.

You will work with the Director, Regulatory Affairs & Quality Assurance and cross-functional partners to ensure timely COFEPRIS filings, approvals, and post-approval changes, while maintaining an integrated regulatory portfolio. The role requires 5+ years in pharma regulatory strategy, bilingual English/Spanish, CTD