Remote Regulatory Strategy Consultant

Parexel; United States; On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Regulatory Strategy Consultant in a remote capacity to lead regulatory strategy across major programs, engage with authorities, and guide high-impact submissions. You will collaborate with biopharmaceutical partners to shape pathways and lifecycle planning, contributing to development timelines and market opportunities.

This role emphasizes strategic regulatory leadership, lifecycle management, and cross-functional teamwork within a growth-focused environment focused on

Qualifications

• 10+ years of experience in regulatory affairs, clinical development, or related field.
• Bachelor's degree in life sciences, pharmacy, medicine, or related field.
• Experience with vaccine and/or biologic products.
• Deep knowledge of ICH-GCP, FDA and international regulatory requirements, and clinical trial processes.

Responsibilities

• Own and develop regulatory strategy across significant programs or portfolios, ensuring alignment with business objectives and regulatory requirements
• Provide leadership on major regulatory decisions, including authority engagement models, submission strategies, and risk mitigation approaches
• Lead the planning and execution of high-impact regulatory submissions, coordinating cross-functional teams and ensuring compliance with regulatory requirements
• Develop and implement long-range development and lifecycle management plans that optimize regulatory pathways and commercial outcomes
• Collaborate with clinical, scientific, and commercial teams to align regulatory strategy with development timelines and market opportunities
• Monitor regulatory landscape changes and provide strategic recommendations to adapt development and submission approaches

Skills

Regulatory strategy

Cross-functional leadership

Regulatory affairs

Clinical development

Education

Bachelor's degree in life sciences

Tools

Regulatory databases

Submission management systems

Job description

Parexel is seeking a Regulatory Strategy Consultant in a remote capacity to lead regulatory strategy across major programs, engage with authorities, and guide high-impact submissions. You will collaborate with biopharmaceutical partners to shape pathways and lifecycle planning, contributing to development timelines and market opportunities.

This role emphasizes strategic regulatory leadership, lifecycle management, and cross-functional teamwork within a growth-focused environment focused on