Regulatory Strategy Consultant

Job overview

The Regulatory Strategy Consultant is a remote role based in Carson City, NV. Compensation is not specified for this position, which supports Parexel's regulatory team in advancing clinical development programs. This role provides strategic leadership for major regulatory decisions, authority engagement, and high-impact submissions. The consultant works with biopharmaceutical partners to shape regulatory pathways and lifecycle management plans, ensuring alignment with business objectives and global regulatory requirements.

What you'll do

• Develop regulatory strategy for significant programs.
• Lead authority engagement models and submission strategies.
• Coordinate cross-functional teams for high-impact submissions.
• Monitor regulatory landscape changes.
• Collaborate with clinical and commercial teams to optimize development timelines.
• Provide strategic recommendations for risk mitigation.

What we're looking for

Skills & competencies

full-time

day shift

carson city nv

parexel

remote

regulatory strategy

biologics

vaccines

consulting

healthcare

Work arrangement

• Weekend coverage required

Benefits & perks

• Health, Vision & Dental Insurance, 401(k) with match, tuition reimbursement, paid time off.

Why this role

Requires 10+ years of 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.