Remote Regulatory Strategy Leader – Biopharma

Parexel; Pierre (SD); Remote; USD 180,000 - 240,000; Full time

Benefits offered by this job

Health Insurance

Tuition Reimbursement

Paid Time Off

Flexible Spending Account

Work/Life Balance

401(k) Match

Pet Insurance

Job summary

Parexel is seeking a Regulatory Strategy Consultant to join our team in a remote capacity. You will lead regulatory strategy across major programs, guide authority engagement models, and drive high-impact submissions for vaccines and biologics.

This role emphasizes strategic regulatory planning, lifecycle management, and cross-functional collaboration with biopharmaceutical partners. You will work in a fast-paced environment focused on advancing clinical development, shaping regulatory pathways,

Qualifications

• Bachelor's degree in life sciences, pharmacy, medicine, or related field or equivalent experience.
• 10+ years in regulatory affairs, clinical development, or related field.
• Experience with vaccine and/or biologic products required.
• Deep knowledge of ICH-GCP, FDA and international regulatory requirements and trial processes.
• Experience with regulatory tracking systems, electronic submission tools, and clinical development platforms.
• Excellent communication, strategic planning, and problem-solving with leadership ability.

Responsibilities

• Own and develop regulatory strategy across significant programs or portfolios, aligned with regulatory requirements.
• Provide leadership on major regulatory decisions, including authority engagement models and submission strategies.
• Lead planning and execution of high-impact regulatory submissions with cross-functional teams.
• Develop long-range development and lifecycle management plans to optimize regulatory pathways.
• Collaborate with clinical, scientific, and commercial teams to align strategy with timelines and market opportunities.
• Monitor regulatory landscape changes and adapt development and submission approaches.

Skills

Regulatory strategy

Cross-functional leadership

Strategic planning

Regulatory leadership

Communication skills

Education

Bachelor's degree in life sciences/related field

Advanced degree (M.D./Ph.D./MBA) or RAC (preferred)

Tools

Regulatory tracking systems

Electronic submission tools

Clinical development platforms

Job description

Parexel is seeking a Regulatory Strategy Consultant to join our team in a remote capacity. You will lead regulatory strategy across major programs, guide authority engagement models, and drive high-impact submissions for vaccines and biologics.

This role emphasizes strategic regulatory planning, lifecycle management, and cross-functional collaboration with biopharmaceutical partners. You will work in a fast-paced environment focused on advancing clinical development, shaping regulatory pathways,