Remote Regulatory Strategy Leader

Parexel; Jackson (MS); Remote; USD 180,000 - 240,000; Full time

Benefits offered by this job

Health insurance

Tuition reimbursement

Paid time off

FSAs/HSAs

Work-life balance

401(k) 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 major programs, lead authority engagement models, and guide high-impact submissions, driving lifecycle planning and development strategies.

You will collaborate with biopharma partners, clinical, scientific, and commercial teams to align regulatory plans with development timelines and market opportunities, ensuring regulatory excellence.

Qualifications

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

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 regulatory plans.
• Monitor regulatory landscape changes and advise on strategy.

Skills

Regulatory strategy

Strategic planning

Cross-functional leadership

Regulatory affairs

Communication skills

Problem-solving

Education

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

Job description

Parexel is seeking a Regulatory Strategy Consultant to join our team in a remote capacity. You will own regulatory strategy across major programs, lead authority engagement models, and guide high-impact submissions, driving lifecycle planning and development strategies.

You will collaborate with biopharma partners, clinical, scientific, and commercial teams to align regulatory plans with development timelines and market opportunities, ensuring regulatory excellence.