Regulatory Strategy Consultant

Job overview

The Regulatory Strategy Consultant is an onsite role based in Des Moines, IA. Compensation is not specified for this position, which supports the Regulatory team at Parexel in advancing clinical development through strategic planning and authority engagement. This role exists to lead regulatory strategy across significant programs and portfolios, ensuring alignment with business objectives and regulatory requirements. It contributes to the company's mission by guiding long-range development strategies and driving high-impact submissions that bring new treatments to patients.

What you'll do

• Own and develop regulatory strategy across significant programs or portfolios.
• Provide leadership on major regulatory decisions, including authority engagement models and submission strategies.
• Lead the planning and execution of high-impact regulatory submissions.
• Develop and implement long-range development and lifecycle management plans.
• Collaborate with clinical, scientific, and commercial teams to align regulatory strategy with development timelines.

What we're looking for

Skills & competencies

full-time

day shift

des moines ia

parexel

regulatory strategy

clinical development

biologics

vaccines

regulatory affairs

onsite

Work arrangement

• Weekend coverage required

Benefits & perks

• Health, Vision & Dental Insurance, Tuition Reimbursement, 401(k) with Company match, Vacation/Holiday/Sick Time, Flexible Spending & Health Savings Accounts

Why this role

Requires 10+ years of experience in regulatory affairs or clinical development, with specific experience in vaccine and/or biologic products.

About the employer

Parexel is hiring for this role. Industry: Administrative Management and General Management Consulting Services. Sector: 54.