LATAM Regulatory Strategy Associate – Infectious Diseases

Parexel; Ciudad de México; Híbrido; MXN 700.000 - 1.100.000; Jornada completa

Descripción de la vacante

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 partner with Global Regulatory, Quality Assurance, and local authorities to ensure timely, compliant filings and lifecycle management.

The role requires 5+ years in regulatory affairs, strong COFEPRIS experience, CTD proficiency, and fluency in English and Spanish. Hybrid work arrangement in Mexico City is available.

Formación

• BA/BS in scientific, engineering, or healthcare discipline.
• 5+ years in pharmaceutical industry, LATAM preferred.
• 3+ years in regulatory strategy or related training.
• Fluent English and Spanish (written and spoken).
• Strong knowledge of US and EU regulations.
• Experience with CTD format and filings.
• Excellent organizational skills.
• Experience preparing regulatory submissions.
• Experience authoring regulatory documents.
• Knowledge of drug development regulations.

Responsabilidades

• Support regulatory strategy and lifecycle planning.
• Assess regulatory impact of proposed global changes and submission requirements.
• Identify regulatory risks, issues, dependencies, and mitigation actions.
• Maintain regulatory plans, submission schedules, trackers, and status reports.
• Coordinate COFEPRIS submissions and post-approval activities.
• Coordinate labeling and artwork regulatory activities.
• Ensure regulatory records are documented in Moderna regulatory systems.

Conocimientos

Regulatory strategy

Regulatory submissions

CTD

Regulatory intelligence

Bilingual English/Spanish

Educación

BA/BS degree

Masters/PhD preferred

Descripción del empleo

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 partner with Global Regulatory, Quality Assurance, and local authorities to ensure timely, compliant filings and lifecycle management.

The role requires 5+ years in regulatory affairs, strong COFEPRIS experience, CTD proficiency, and fluency in English and Spanish. Hybrid work arrangement in Mexico City is available.