Regulatory Strategy Consultant

Parexel; Lincoln (NE); Remote; USD 140,000 - 210,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Regulatory Strategy Consultant to join our team in a remote capacity. You will own regulatory strategy across significant programs, provide leadership for regulatory decisions, and guide lifecycle planning to accelerate clinical development.

In this fast-paced, cross-functional role you will collaborate with biopharmaceutical partners, coordinate submissions, and shape regulatory pathways across therapeutic areas.

Qualifications

• Bachelor’s degree in life sciences, pharmacy, medicine, or related field; or equivalent experience.
• 10+ years in regulatory affairs or clinical development.
• Vaccine/biologic experience preferred.
• Deep knowledge of ICH-GCP, FDA and international requirements; clinical trial processes.
• Experience with regulatory tracking systems and submission tools.
• Excellent communication, strategic planning, and leadership abilities.

Responsibilities

• Own and develop regulatory strategy across significant programs or portfolios.
• Provide leadership on major regulatory decisions, authority engagement, and submission strategies.
• Lead planning and execution of high-impact regulatory submissions with cross-functional teams.
• Develop long-range development and lifecycle plans to optimize pathways and outcomes.
• Collaborate with clinical, scientific, and commercial teams to align strategy with timelines.
• Monitor regulatory changes and adapt development and submission approaches.

Skills

Regulatory strategy

Cross-functional leadership

Clinical development

Regulatory affairs

Communication

Problem solving

Education

Bachelor’s degree in life sciences or related field

Advanced degree or regulatory certification preferred

Tools

Regulatory tracking systems

Electronic submission tools

Clinical development platforms

Job description

Please note - This position is part of a talent pool created in anticipation of future opportunities within our Regulatory team. Candidates may be considered for upcoming roles as business needs evolve.

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

• 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.

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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EEO Disclaimer

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