Strategic Regulatory Leader — Remote

Parexel; Sacramento (CA); Remote; USD 150,000 - 230,000; 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 and portfolios, providing leadership for major regulatory decisions, authority engagement models, and high-impact submissions.

This role supports long-range development and lifecycle planning, collaborating with clinical, scientific, and commercial teams to align strategy with timelines and market opportunities.

Qualifications

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

Responsibilities

• Own and develop regulatory strategy across programs ensuring regulatory alignment.
• Provide leadership on regulatory decisions, submission strategies, and risk mitigation.
• Lead the planning and execution of high-impact regulatory submissions with cross-functional teams.
• Develop long-range development and lifecycle plans to optimize regulatory pathways.
• Collaborate with clinical, scientific, and commercial teams to align strategy with timelines and market opportunities.
• Monitor regulatory landscape changes and adapt development and submission approaches.

Skills

Regulatory strategy

Strategic planning

Cross-functional leadership

Clinical development experience

Regulatory affairs

Leadership

Communication skills

Education

Bachelor's degree in life sciences 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 supports long-range development and lifecycle planning, collaborating with clinical, scientific, and commercial teams to align strategy with timelines and market opportunities.