Regulatory Strategy Consultant

🕒 October 16

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🧐 Strategy

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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, ensuring alignment with business objectives and regulatory requirements • Provide leadership on major regulatory decisions, including authority engagement models, submission strategies, and risk mitigation approaches • Lead the planning and execution of high-impact regulatory submissions, coordinating cross-functional teams and ensuring compliance with regulatory requirements • Develop and implement long-range development and lifecycle management plans that optimize regulatory pathways and commercial outcomes • Collaborate with clinical, scientific, and commercial teams to align regulatory strategy with development timelines and market opportunities • Monitor regulatory landscape changes and provide strategic recommendations to adapt development and submission approaches • Shape regulatory pathways and guide long-range development strategies with biopharmaceutical partners • Drive submissions that bring new treatments to patients • Contribute to long-range development and lifecycle planning

🎯 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 • Strengths in regulatory strategy, strategic planning, and cross-functional leadership • Extensive experience in clinical development, regulatory affairs, or a highly regulated environment • Ability to lead across teams, influence stakeholders, and communicate complex regulatory concepts clearly • Patient-focused mindset and strong attention to regulatory detail and compliance • Comfort working with regulatory databases, submission management systems, and collaborative platforms • Advanced degree or regulatory certification 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 • Flexible work arrangements • Continuous learning opportunities • Career paths and opportunities to expand expertise across therapeutic areas and development phases • Potential eligibility for additional incentives, bonuses, or other compensation programs

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