Regulatory Strategy Consultant

Job overview

The Regulatory Strategy Consultant is an onsite role based in Lincoln, NE. Compensation is not specified for this position, which supports the Regulatory team in advancing clinical development. This role exists to own regulatory strategy across significant programs and portfolios, providing leadership for major regulatory decisions and high-impact submissions. It contributes to the company's goals by shaping regulatory pathways and driving 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.
• 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.

What we're looking for

Skills & competencies

full-time

day shift

lincoln ne

regulatory strategy

clinical development

biopharma

regulatory affairs

ich-gcp

fda

onsite

Work arrangement

• Weekend coverage required

Benefits & perks

• Health, Vision & Dental Insurance, Tuition Reimbursement, 401(k) with Company match, Pet Insurance

Why this role

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

About the employer

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