Remote Regulatory Strategy Leader for Clinical Programs

Parexel; Olympia (WA); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings Ac.

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel seeks 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.

You’ll work with biopharmaceutical partners to shape regulatory pathways and drive submissions that bring new treatments to patients. You’ll join a fast-paced environment focused on strategic regulatory leadership and

Qualifications

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

Responsibilities

• Develop regulatory strategy across programs and portfolios.
• Lead authority engagement models and submission planning.
• Coordinate cross-functional teams for high-impact submissions.
• Develop long-range development and lifecycle plans.
• Collaborate with clinical, scientific and commercial teams.
• Monitor regulatory landscape and advise on strategy changes.

Skills

Regulatory strategy

Strategic planning

Cross-functional leadership

Regulatory affairs

Clinical development

Communication

Leadership

Regulatory detail

Education

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

10+ years of experience in regulatory affairs / clinical development

Tools

Regulatory tracking systems

Electronic submission tools

Clinical development platforms

Job description

Parexel seeks 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.

You’ll work with biopharmaceutical partners to shape regulatory pathways and drive submissions that bring new treatments to patients. You’ll join a fast-paced environment focused on strategic regulatory leadership and