Regulatory Strategy Consultant

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🧐 Strategy

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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

• Own and develop regulatory strategy across significant programs or portfolios • Provide leadership on major regulatory decisions, authority engagement models, submission strategies, and risk mitigation approaches • Lead planning and execution of high-impact regulatory submissions • Coordinate cross-functional teams and ensure compliance with regulatory requirements • Develop and implement long-range development and lifecycle management plans • Collaborate with clinical, scientific, and commercial teams • Monitor regulatory landscape changes and provide strategic recommendations • Shape regulatory pathways and guide long-range development strategies for biopharmaceutical partners

🎯 Requirements

• Bachelor's degree in life sciences, pharmacy, medicine, or related field, or equivalent professional experience • 10+ years of experience in regulatory affairs, clinical development, or related field • Previous experience with vaccine and/or biologic products is required • Deep knowledge of ICH-GCP, FDA and international regulatory requirements, and clinical trial processes • Experience with regulatory tracking systems, electronic submission tools, and clinical development platforms • Excellent communication, strategic planning, and problem-solving skills with demonstrated leadership ability • Advanced degree (M.D., Ph.D., or M.B.A.) or regulatory certification (e.g., RAC) preferred • Experience in multiple therapeutic areas or development phases preferred • Familiarity with global regulatory frameworks and international submission strategies preferred • Fluency in additional languages relevant to regulatory submissions preferred

🏖️ Benefits

• Health, Vision & Dental Insurance • Tuition Reimbursement • Vacation/Holiday/Sick Time • Flexible Spending & Health Savings Accounts • Work/Life Balance • 401(k) with Company match • Pet Insurance • Paid time off • Life insurance • Some roles may be eligible for additional incentives, bonuses, or other compensation programs