Regulatory Strategy Consultant

Parexel•Southport, NC

1d•Remote

About The Position

This position is part of a talent pool created in anticipation of future opportunities within Parexel's Regulatory team. Candidates may be considered for upcoming roles as business needs evolve. Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With over 22,000 employees worldwide, Parexel partners 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. The company works with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. They embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. Parexel is expanding its team and seeking talented individuals to help drive industry-leading innovation. 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.

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
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

Nice To Haves

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

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