Regulatory Strategy Consultant

Overview

As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.

We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.

Success Profile

Do you have these soft skills and interpersonal traits to succeed at Parexel?

• Communicator
• Detail-oriented
• Problem-solver
• Relationship-builder
• Results-driven
• Strategic

About This Role

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose -- moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart(R).

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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• LI-REMOTE

• EEO Disclaimer

• Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

• Employee Insights

• How to describe Parexel culture in one word

• Insights from Parexel employees

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• Jo on diverse project work and team culture

• Jo Wang | Vice President, Technical

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• Kurt on colleagues and growth opportunities

• Kurt Brorson | Vice President, Technical

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• Why Consultants work at Parexel

• Patient-led in everything we do

• We are inspired by the patients behind the data and therefore deliver first-time quality and on-time projects.

• Supportive and inclusive environment

• We thrive on collaboration, caring, and inclusivity - enabling our people to work together to solve complex problems and share knowledge.

• Opportunities for career growth

• We provide a wide range of challenging assignments, product types, geographic regions, and therapeutic areas, providing ample opportunities for learning and growth.

• Flexible work arrangements

• We offer the flexibility of remote work, allowing you to balance your personal and professional responsibilities while still contributing to our “We Care” team environment.

• Diverse and global client exposure

• We continuously learn by working with a global network of colleagues and clients to develop regulatory strategies to support their product development and approval.

• Learn from experts

• You will work with a team of highly experienced regulatory professionals who can serve as mentors, providing guidance and support as you develop your skills and advance in your career.

• Learn About Our Culture

• Careers in Neuroscience

• Neuroscience diseases affect the very core of one’s being and experience. We work diligently to lighten the burden for patients and families alike. Explore opportunities to join our team.

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• Careers in Cell and Gene

• Cell and gene therapies (CAGT) have rapidly emerged as among the fastest-growing spaces in all of biopharma R&D, and Parexel was an early entrant into this space.

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• Our work culture

• Learn about our culture, perks, learning opportunities, and our corporate responsibility approach. Parexel's compassionate and results-driven work cultu