Regulatory Affairs Associate (México)

Regulatory Affairs Associate (México)

13 ago
|
Parexel
|
México

13 ago

Parexel

México

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 compliance for clinical trials in Mexico, working closely with multidisciplinary teams and regulatory authorities.
The adecuado candidate will be a professional with knowledge 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

📌 Regulatory Affairs Associate (México)
🏢 Parexel
📍 México

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