Remote Regulatory Strategy Leader for Biotech Programs

Parexel; Tallahassee (FL); Remote; USD 150,000 - 190,000; Full time

Benefits offered by this job

Health Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Regulatory Strategy Consultant to own regulatory strategy across major programs, guiding lifecycle management and high-impact submissions. You will engage with authority models and cross-functional teams to shape development plans and ensure regulatory compliance.

The role emphasizes strategic leadership, global regulatory knowledge, and collaboration with clinical, scientific, and commercial groups to drive timely submissions and market access.

Qualifications

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

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

Strategic planning

Cross-functional leadership

Regulatory affairs expertise

Communication

Problem-solving

Leadership ability

Education

Bachelor's degree in life sciences/pharmacy/medicine or related field

Advanced degree (M.D., Ph.D., or MBA) or RAC certification

Tools

Regulatory tracking systems

Electronic submission tools

Submission management platforms

Clinical development platforms

Job description

Parexel is seeking a Regulatory Strategy Consultant to own regulatory strategy across major programs, guiding lifecycle management and high-impact submissions. You will engage with authority models and cross-functional teams to shape development plans and ensure regulatory compliance.

The role emphasizes strategic leadership, global regulatory knowledge, and collaboration with clinical, scientific, and commercial groups to drive timely submissions and market access.