Regulatory Strategy Consultant
Parexel
Summary
We are seeking a Regulatory Strategy Consultant to join our team in a remote capacity. As a Regulatory Strategy Consultant, you will own regulatory strategy across significant programs and portfolios, providing leadership for major regulatory decisions, authority engagement models, and high-impact submissions. This position plays a key role in advancing clinical development through strategic regulatory planning, lifecycle management, and cross-functional collaboration. You'll work with biopharmaceutical partners to shape regulatory pathways, guide long-range development strategies, and drive submissions that bring new treatments to patients.
Job description
About the Role
We are seeking a Regulatory Strategy Consultant to join our team in a remote capacity. As a Regulatory Strategy Consultant, you will own regulatory strategy across significant programs and portfolios, providing leadership for major regulatory decisions, authority engagement models, and high-impact submissions. This position plays a key role in advancing clinical development through strategic regulatory planning, lifecycle management, and cross-functional collaboration. You'll work with biopharmaceutical partners to shape regulatory pathways, guide long-range development strategies, and drive submissions that bring new treatments to patients.
Key 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
Candidate Profile
- Strengths in regulatory strategy, strategic planning, and cross-functional leadership
- Extensive experience in clinical development, regulatory affairs, or a highly regulated environment
- The ability to lead across teams, influence stakeholders, and communicate complex regulatory concepts clearly
- A patient-focused mindset and strong attention to regulatory detail and compliance
- Comfort working with regulatory databases, submission management systems, and collaborative platforms
Required 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
- 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
Preferred Qualifications
- 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
Requirements
- 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
Benefits
- Health Insurance
- Vision Insurance
- Dental Insurance
- Tuition Reimbursement
- Vacation Time
- Holiday Time
- Sick Time
- Flexible Spending Account
- Health Savings Account
- 401(k) with Company Match
- Pet Insurance
- Life Insurance
Company overview
Parexel is one of the world's largest and most prominent contract research organizations (CROs), providing comprehensive clinical research services to pharmaceutical and biotechnology companies globally. Founded in 1982 and headquartered in Raleigh, North Carolina, Parexel operates with a global workforce of over 24,000 professionals across 84+ facilities in 49 countries. The company specializes in managing the full spectrum of clinical trials from Phase I to IV across diverse therapeutic areas including neuroscience, oncology, infectious diseases, hematology, and general medicine. Parexel offers end-to-end solutions encompassing clinical trial management, regulatory strategy, data management, biostatistics, pharmacovigilance, medical communications, and market access consulting. With a strong track record spanning over 40 years, Parexel has established itself as a trusted partner for both established pharmaceutical leaders and emerging biotech innovators, helping accelerate drug development and bring life-saving treatments to patients faster through its patient-centric approach and operational excellence.