Senior Regulatory Strategy Associate

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

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

• Develop and recommend regulatory pathways for assigned products, studies, or markets • Support agency engagement planning and prepare materials for regulatory meetings • Identify key regulatory risks and opportunities to inform development strategy • Align regulatory approaches with development and commercialization objectives • Maintain current knowledge of regulatory requirements and industry guidance • Collaborate with cross-functional teams to ensure regulatory compliance and strategic alignment • Prepare regulatory documentation and submissions as needed • Track regulatory timelines and milestones to support program execution

🎯 Requirements

• Bachelor's degree in life sciences, regulatory affairs, pharmacy, or related field, or equivalent professional experience • 4+ years of experience in regulatory affairs, clinical development, or a related field • Previous experience with vaccine and/or biologic products is required • FDA regulation expertise/knowledge is required • Knowledge of ICH-GCP, regulatory requirements, and clinical trial processes • Experience with regulatory databases or submission tracking systems • Strong communication, organization, and problem-solving skills • Experience working in regulatory affairs, clinical development, or a regulated environment • Ability to collaborate across teams and communicate clearly with internal and external stakeholders • Patient-focused mindset and strong attention to detail • Comfort working with regulatory databases, submission tracking systems, and standard office tools • Advanced degree in regulatory affairs, pharmacy, or related field preferred • Experience with other global markets preferred • Familiarity with regulatory submission software or electronic tracking systems preferred • Experience supporting FDA or international regulatory submissions preferred

🏖️ Benefits

• Remote work flexibility • Continuous learning opportunities • Career paths and skill expansion across regulatory affairs and clinical development • Flexible, growth-oriented work environment