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
- 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 prepa