Remote Regulatory Strategy Lead for Clinical Development

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

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.