Remote Regulatory Strategy Lead

Parexel; Saint Paul (MN); Remote; USD 180,000 - 240,000; Full time

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 and submissions.

This role drives long-range development, lifecycle management, and cross-functional collaboration with biopharmaceutical partners to shape regulatory pathways and guide development strategies.

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 and/or biologic products.
• Deep knowledge of ICH-GCP, FDA and international regulatory requirements.
• Excellent communication and leadership skills.

Responsibilities

• Own regulatory strategy across significant programs and portfolios.
• Lead major regulatory decisions, including authority engagement models, submission strategies, and risk mitigation approaches.
• Plan and execute high-impact regulatory submissions, coordinating cross-functional teams.
• Develop and implement long-range development and lifecycle management plans.
• Collaborate with clinical, scientific, and commercial teams to align regulatory strategy with development timelines.
• Monitor regulatory landscape changes and advise on development and submission approaches.

Skills

Regulatory strategy

Cross-functional leadership

Clinical development experience

FDA/ICH knowledge

Submission management

Stakeholder influence

Education

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

Tools

Regulatory databases

Submission management systems

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 and submissions.

This role drives long-range development, lifecycle management, and cross-functional collaboration with biopharmaceutical partners to shape regulatory pathways and guide development strategies.