Remote Regulatory Strategy Leader

Parexel; Springfield (IL); Remote; USD 150,000 - 210,000; Full time

Benefits offered by this job

Health 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, guiding submissions and authority engagement to advance clinical development.

This role requires deep regulatory expertise, leadership, and collaboration with diverse partners to shape development timelines and lifecycle plans. You will work with biopharmaceutical partners to drive strategic regulatory planning, lifecycle management, and

Qualifications

• Bachelor’s degree in life sciences, pharmacy, medicine, or related field required.
• 10+ years of experience in regulatory affairs or clinical development.
• Experience with vaccine and/or biologic products required.
• Deep knowledge of ICH-GCP, FDA and international regulatory requirements.
• Experience with regulatory tracking systems and electronic submissions.

Responsibilities

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

Skills

Regulatory strategy

Cross-functional leadership

Regulatory affairs

Strategic planning

Leadership

Education

Bachelor's degree in life sciences/related field

Advanced degree (MD/PhD/MBA) preferred

Regulatory certification (RAC) preferred

Tools

Regulatory databases

Submission management systems

Electronic submission tools

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, guiding submissions and authority engagement to advance clinical development.

This role requires deep regulatory expertise, leadership, and collaboration with diverse partners to shape development timelines and lifecycle plans. You will work with biopharmaceutical partners to drive strategic regulatory planning, lifecycle management, and