Regulatory Strategy Consultant

Parexel; Harrisburg (Dauphin County); Remote; USD 140,000 - 200,000; Full time

Benefits offered by this job

Health Insurance

Tuition Reimbursement

401(k) with Company match

Vacation/Holiday/Sick Time

Work/Life Balance

Pet Insurance

Job summary

Parexel is seeking a Regulatory Strategy Consultant to lead regulatory strategy across major programs in a remote role. You will guide authority engagement, submissions, and lifecycle planning to accelerate clinical development and market access.

The role demands extensive experience in regulatory affairs, a deep understanding of ICH-GCP and FDA/ international regulations, and the ability to collaborate with clinical, scientific, and commercial teams.

Qualifications

• Bachelor's degree in life sciences, pharmacy, medicine, or related field.
• 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.

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.

Skills

Regulatory strategy

Cross-functional leadership

Clinical development

Regulatory affairs

Vaccine/biologic experience

ICH-GCP

FDA regulations

Submission management

Regulatory databases

Electronic submission tools

Education

Bachelor's degree in life sciences

Tools

Regulatory databases

Submission tracking systems

Electronic submission tools

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.

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.

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.

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.