LATAM Regulatory Strategist - ID & Biologics

Parexel; Ciudad de México; On-site; MXN 850,000 - 1,500,000; Full time

Job summary

Parexel, a global clinical research partner, seeks a Regulatory Affairs Sr. Associate focused on LATAM COFEPRIS interactions to support product lifecycle management.

You will drive regulatory strategy, oversee submissions, labeling reviews, and post‑approval changes, collaborating with global and regional teams to ensure timely, compliant approvals.

The role requires 5+ years in pharma, strong English and Spanish, and a track record with CTD submissions and regulatory filings across LATAM.

Qualifications

• 5+ years in the pharmaceutical industry, preferably LATAM.
• Exceptional written and oral English and Spanish communication.
• Strong knowledge of US/EU regulations and CTD format.

Responsibilities

• Support regulatory strategies and assess global changes with timelines.
• Identify regulatory risks and escalate with mitigation actions.
• Coordinate labeling and artwork regulatory activities and updates.
• Maintain regulatory portfolio with registrations, submissions, and milestones.
• Own regulatory activities end-to-end, ensuring timely completion.

Skills

Regulatory strategy

COFEPRIS

Regulatory submissions

Regulatory writing

Cross-functional coordination

Education

BA/BS degree in a scientific, engineering, or healthcare discipline

Job description

Parexel, a global clinical research partner, seeks a Regulatory Affairs Sr. Associate focused on LATAM COFEPRIS interactions to support product lifecycle management.

You will drive regulatory strategy, oversee submissions, labeling reviews, and post‑approval changes, collaborating with global and regional teams to ensure timely, compliant approvals.

The role requires 5+ years in pharma, strong English and Spanish, and a track record with CTD submissions and regulatory filings across LATAM.