Regulatory Strategy Specialist LATAM Infectious Diseases

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

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.