Regulatory Affairs Associate – Clinical Trials Submissions

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• 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

🎯 Requirements

• Bachelor's degree in Health Sciences, Chemistry, Pharmacobiology, or related fields (required) • Postgraduate degree in Regulatory Affairs or related areas (desirable) • Minimum 1-2 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 • Knowledge of Mexican regulations for clinical trials • Ability to manage multiple projects and prepare complex regulatory dossiers • Good at handling of the DIGIPRIS platform • Excellent technical writing skills for COFEPRIS responses • 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.

🏖️ Benefits

• 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