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Regulatory Affairs Associate - Clinical Trials submissions (Mexico)

🇲🇽 Mexico

Consulting

Legal

APPLY

from 🇲🇽 Mexico

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

We are seeking a Regulatory Affairs professional with experience in regulatory Submissions of Clinical Trials, located in México

## Parexel International | Mexico City, Mexico

About Parexel

Parexel is a leading clinical research organization (CRO) working with pharmaceutical and biotechnology clients worldwide to accelerate the development of innovative treatments that improve patient health. With a global presence and expertise across all phases of clinical development, Parexel offers a dynamic environment where professionals can grow and contribute to advancing medicine.

Position Overview

We are seeking a highly qualified Regulatory Affairs Associate to join our Regulatory Affairs team in Mexico. This role is critical to ensuring regulatory compliancefor clinical trials in Mexico, working closely with multidisciplinary teams and regulatory authorities.

The ideal candidate will be a professional withknowledge of Mexican regulations, capable of developing comprehensive regulatory strategies and managing multiple projects simultaneously.

Key Responsibilities

Implement comprehensive regulatory strategies for clinical trials in Mexico
Prepare, review, and submit regulatory dossiers to COFEPRIS and Ethics Committees
Manage the complete regulatory submission process under the new simplification agreement
Utilize the DIGIPRIS platform for regulatory procedures and tracking
Prepare high-quality technical responses to COFEPRIS requirements
Maintain effective communication with regulatory authorities and ethics committees
Provide expert regulatory guidance to internal teams and clients
Monitor changes in Mexican regulations and assess their impact on projects
Ensure compliance with timelines and quality standards for all deliverables
Collaborate with global and local teams in the execution of clinical studies

Technical Requirements

Essential Knowledge:

Knowledge of Mexican regulations for clinical trials
Ability to manage multiple projects and prepare complex regulatory dossiers
Good at handling of the DIGIPRIS platform
Knowledge of the submission process to both ethics committees and COFEPRIS
Experience in assembling regulatory dossiers under the new simplification agreement
Excellent technical writing skills for COFEPRIS responses

Required Skills:

Proficiency in English (oral and written)
Excellent organizational skills and attention to detail
Ability to work under pressure and meet strict deadlines
Effective communication skills with diverse stakeholders
Proactivity and problem-solving capabilities

Qualifications

Education:

Bachelor's degree in Health Sciences, Chemistry, Pharmacobiology, or related fields (required)
Postgraduate degree in Regulatory Affairs or related areas (desirable)

Experience:

Minimum 1-2 years of experience in regulatory affairs forclinical trials in Mexico
Demonstrable experience with submissions to COFEPRIS and ethics committees
Proven track record of successfully managing multiple regulatory projects