Regulatory Affairs Specialist - Mexico (Hybrid)

Parexel International; Ciudad de México; Hybrid; MXN 900,000 - 1,150,000; Full time

Job summary

Parexel International is seeking a Consultant, Regulatory Affairs in Mexico City to provide operational regulatory support to the Director, Regulatory Affairs & Quality Assurance. You will coordinate submissions, lifecycle maintenance, and tracking across the product lifecycle, collaborating with cross-functional teams to ensure timely regulatory actions.

The role requires 5+ years in Regulatory Affairs, strong COFEPRIS knowledge, and fluency in Spanish and English.

Qualifications

• BA/BS in scientific/healthcare field.
• 5+ years regulatory affairs experience in pharmaceutical/biotech.
• Strong knowledge of Mexican regulatory framework and COFEPRIS.
• Experience with CTD format and regulatory filings.
• Experience preparing regulatory submissions and responses to health authority questions.
• Strong Spanish and English communication.
• Ability to work in a hybrid model in Mexico City (50% office).

Responsibilities

• Support Director in executing regulatory strategies for Mexico across the product lifecycle.
• Coordinate regulatory assessments and changes affecting Mexico.
• Review labeling and artwork regulatory activities.
• Prepare submissions, responses, commitments, and post-approval activities for COFEPRIS.
• Maintain Mexico regulatory portfolio and trackers.
• Provide regulatory intelligence and risk assessments.

Skills

Regulatory Affairs

COFEPRIS procedures

CTD format knowledge

Regulatory submissions

Cross-functional teamwork

Bilingual Spanish/English

Education

BA/BS degree in a scientific field

Master's, PharmD, or PhD (Preferred)

Job description

Parexel International is seeking a Consultant, Regulatory Affairs in Mexico City to provide operational regulatory support to the Director, Regulatory Affairs & Quality Assurance. You will coordinate submissions, lifecycle maintenance, and tracking across the product lifecycle, collaborating with cross-functional teams to ensure timely regulatory actions.

The role requires 5+ years in Regulatory Affairs, strong COFEPRIS knowledge, and fluency in Spanish and English.