Regulatory Strategy Consultant

Job overview

The Regulatory Strategy Consultant is an onsite role based in Helena, MT. Compensation is not specified for this position, which supports the regulatory team at Parexel. This role exists to own regulatory strategy across significant programs and portfolios, providing leadership for major regulatory decisions and high-impact submissions. The consultant guides long-range development strategies and collaborates with biopharmaceutical partners to 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.
• 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.
• Monitor regulatory landscape changes and provide strategic recommendations.

What we're looking for

Skills & competencies

full-time

day shift

helena mt

parexel

regulatory affairs

strategy consultant

onsite

clinical development

biologics

vaccines

Work arrangement

• Weekend coverage required

Benefits & perks

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

Why this role

Requires 10+ years of regulatory affairs experience and previous work with vaccine or biologic products.

About the employer

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