Remote Regulatory Strategy Leader - Clinical Development

Parexel; Raleigh (NC); Remote; USD 140,000 - 210,000; Full time

Benefits offered by this job

Health Insurance

Tuition Reimbursement

Vacation/Sick Time

FSAs/HSA

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Regulatory Strategy Consultant to lead regulatory strategy across major programs in a remote capacity. You will guide authority engagement, oversee high-impact submissions, and shape lifecycle plans while collaborating with clinical, scientific, and commercial teams.

The role demands deep regulatory knowledge (ICH-GCP, FDA) and a track record of strategic leadership in biopharma, with a focus on vaccines or biologics.

Qualifications

• Bachelor's degree in life sciences or related field; 10+ years in regulatory affairs.
• Experience with vaccine and/or biologic products is required.
• Deep knowledge of ICH-GCP, FDA regulations, and clinical trial processes.
• Excellent communication, strategic planning, and problem-solving with leadership ability.

Responsibilities

• Own and develop regulatory strategy across significant programs or portfolios, aligning 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, coordinating 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 advise on adaptive strategies.

Skills

Regulatory strategy

Cross-functional leadership

Strategic planning

Communication

Regulatory affairs knowledge

Education

Bachelor's degree in life sciences

Tools

Regulatory submission systems

Job description

Parexel is seeking a Regulatory Strategy Consultant to lead regulatory strategy across major programs in a remote capacity. You will guide authority engagement, oversee high-impact submissions, and shape lifecycle plans while collaborating with clinical, scientific, and commercial teams.

The role demands deep regulatory knowledge (ICH-GCP, FDA) and a track record of strategic leadership in biopharma, with a focus on vaccines or biologics.