Note: The job is a remote job and is open to candidates in USA. Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. They are seeking a Regulatory Strategy Consultant to own regulatory strategy across significant programs and portfolios, providing leadership for major regulatory decisions and high-impact submissions.
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
- 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
- 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
- Advanced degree (M.D., Ph.D., or M.B.A.) or regulatory certification (e.g., RAC) preferred
- Experience in multiple therapeutic areas or development phases
- Familiarity with global regulatory frameworks and international submission strategies
- Fluency in additional languages relevant to regulatory submissions
Benefits
- Health, Vision & Dental Insurance
- Tuition Reimbursement
- Vacation/Holiday/Sick Time
- Flexible Spending & Health Savings Accounts
- Work/Life Balance
- 401(k) with Company match
- Pet Insurance
- For a complete list of benefits, please visit www.parexel.com/us-benefits.
Company Overview
Company H1B Sponsorship