Regulatory Strategy Consultant

About the Role

We are seeking a Regulatory Strategy Consultant to join our team in a remote capacity. As a Regulatory Strategy Consultant, you will own regulatory strategy across significant programs and portfolios, providing leadership for major regulatory decisions, authority engagement models, and high-impact submissions. This position plays a key role in advancing clinical development through strategic regulatory planning, lifecycle management, and cross-functional collaboration. You'll work with biopharmaceutical partners to shape regulatory pathways, guide long-range development strategies, and drive submissions that bring new treatments to patients. Responsibilities include leading regulatory strategy development, managing authority engagement, overseeing high-impact submissions, and contributing to long-range development and lifecycle planning.

You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through strategic regulatory leadership and advancing clinical research. With diverse teams and continuous learning opportunities, the Regulatory Strategy Consultant can explore career paths and expand expertise across therapeutic areas and development phases.

Key Responsibilities

• 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

Candidate Profile

You'll thrive in this role if you bring:

• Strengths in regulatory strategy, strategic planning, and cross-functional leadership
• Extensive experience in clinical development, regulatory affairs, or a highly regulated environment
• The ability to lead across teams, influence stakeholders, and communicate complex regulatory concepts clearly
• A patient-focused mindset and strong attention to regulatory detail and compliance
• Comfort working with regulatory databases, submission management systems, and collaborative platforms

Required Qualifications

• 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

Preferred Qualifications

• 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
• Familiarity with global regulatory frameworks and international submission strategies
• Fluency in additional languages relevant to regulatory submissions

Benefits and Compensation

• 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

For a complete list of benefits, please visit www.parexel.com/us-benefits.

Some roles may also be eligible for additional incentives, bonuses, or other compensation programs. Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions.

We offer a comprehensive benefits package to eligible employees, which includes paid time off, a 401(k) match, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans.

If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

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