Remote Regulatory Strategy Architect

Parexel; Charleston (WV); Remote; USD 150,000 - 230,000; 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 lead regulatory strategy across major programs, driving authority engagement, submissions, and lifecycle planning. This remote role emphasizes strategic leadership and cross-functional collaboration with biopharmaceutical partners to shape regulatory pathways and development plans.

You will work in a fast-paced, growth-oriented environment focused on impactful regulatory leadership and advancing clinical research across therapeutic areas,

Qualifications

• Bachelor's degree in life sciences, pharmacy, medicine, or related field, or equivalent professional experience
• 10+ years of experience in regulatory affairs, clinical development, or related field
• Experience with vaccine and/or biologic products is required
• Deep knowledge of ICH-GCP, FDA and international regulatory requirements
• 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 regulatory strategy across significant programs or portfolios
• Provide leadership on major regulatory decisions and submission strategies
• Lead planning and execution of high-impact regulatory submissions
• Develop long-range development and lifecycle management plans
• Collaborate with clinical, scientific, and commercial teams to align strategy
• Monitor regulatory landscape changes and provide strategic recommendations

Skills

Regulatory strategy

Strategic planning

Cross-functional leadership

Regulatory databases

Submission management

Excellent communication

Education

Bachelor's degree in life sciences/related field

Advanced degree (MD/PhD/MBA) preferred

Tools

Regulatory tracking systems

Electronic submission tools

Clinical development platforms

Job description

Parexel is seeking a Regulatory Strategy Consultant to lead regulatory strategy across major programs, driving authority engagement, submissions, and lifecycle planning. This remote role emphasizes strategic leadership and cross-functional collaboration with biopharmaceutical partners to shape regulatory pathways and development plans.

You will work in a fast-paced, growth-oriented environment focused on impactful regulatory leadership and advancing clinical research across therapeutic areas,