Remote Regulatory Strategy Lead

Parexel; Phoenix (AZ); Remote; USD 140,000 - 190,000; 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 and portfolios, providing leadership for major regulatory decisions, authority engagement models, and high-impact submissions.

This role drives long-range development and lifecycle planning, collaborating with biopharmaceutical partners to shape regulatory pathways and guide development timelines.

Qualifications

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

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

Strategic planning

Cross-functional leadership

Clinical development experience

Regulatory submission tools

Education

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

Tools

Regulatory tracking systems

Electronic submission tools

Clinical development platforms

Job description

Parexel is seeking a Regulatory Strategy Consultant to join our team in a remote capacity. You will own regulatory strategy across significant programs and portfolios, providing leadership for major regulatory decisions, authority engagement models, and high-impact submissions.

This role drives long-range development and lifecycle planning, collaborating with biopharmaceutical partners to shape regulatory pathways and guide development timelines.