Senior Regulatory Affairs Associate - Clinical Trials

## 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 qualifiedSenior Regulatory Affairs Associateto 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 ideal candidate will be an experienced professional with solid knowledge of Mexican regulations, capable of developing comprehensive regulatory strategies and managing multiple projects simultaneously.

Key Responsibilities

• Develop and implement comprehensive regulatory strategies for clinical trials in Mexico
• Prepare, review, and submit complex 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:

• Extensive knowledge of Mexican regulations for clinical trials
• Proven experience in developing comprehensive regulatory strategies
• Ability to manage multiple projects and prepare complex regulatory dossiers
• Expert handling of the DIGIPRIS platform
• In-depth 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 3-5 years of experience in regulatory affairs for clinical trials in Mexico
• Demonstrable experience with submissions to COFEPRIS and ethics committees
• Proven track record of successfully managing multiple regulatory projects

What We Offer

• Opportunity to work for a leading global CRO
• Innovative projects with top-tier pharmaceutical clients
• Collaborative and multicultural work environment
• Continuous professional development and training
• Competitive compensation package
• Benefits above legal requirements
• Flexible work arrangements

How to Apply

If you meet the requirements and are interested in being part of a team that is transforming drug development, we invite you to apply.

Parexel is an equal opportunity employer.We value diversity and are committed to creating an inclusive environment for all employees.

Note: This position requires eligibility to work in Mexico.