LATAM Regulatory Strategy Consultant – Infectious Diseases

Parexel; Chihuahua; On-site; MXN 1,200,000 - 1,800,000; Full time

Job summary

Parexel is seeking a Consultant of Regulatory Strategy for Mexico with in-office requirements. You will manage regulatory dossiers, guide submissions, and act as a primary liaison with LATAM health authorities.

The role supports infectious diseases programs across Latin America within a global regulatory team. The ideal candidate brings 5+ years in pharma regulatory affairs, strong US/EU regulation knowledge, and proven ability to author regulatory documents and coordinate complex submissions.

Qualifications

• Education: BA/BS in a scientific, engineering, or healthcare discipline (Masters, PharmD, or PhD preferred).
• Experience: 5+ years in the pharmaceutical industry, preferably with LATAM country experience.
• Regulatory Expertise: 3+ years of regulatory strategy experience or relevant equivalent training/experience.
• Technical Knowledge: Strong knowledge of current US and EU regulations.
• CTD: Experience with CTD format and content; regulatory document authoring.

Responsibilities

• Develop and execute regulatory strategy across the product development lifecycle.
• Coordinate regulatory submissions and related supplements and amendments.
• Track and archive correspondence with health authorities; monitor regulatory commitments.
• Collaborate with global teams to align regulatory plans and ensure timely approvals.

Skills

Regulatory strategy

Regulatory excellence

English & Spanish bilingual

Education

BA/BS in science or healthcare

Tools

CTD (Common Technical Document)

Job description

Parexel is seeking a Consultant of Regulatory Strategy for Mexico with in-office requirements. You will manage regulatory dossiers, guide submissions, and act as a primary liaison with LATAM health authorities.

The role supports infectious diseases programs across Latin America within a global regulatory team. The ideal candidate brings 5+ years in pharma regulatory affairs, strong US/EU regulation knowledge, and proven ability to author regulatory documents and coordinate complex submissions.