Regulatory Strategy Consultant

Parexel•Southport, NC

6d•Remote

About The Position

Parexel is seeking a Regulatory Strategy Consultant to work remotely and own regulatory strategy across significant programs and portfolios. The role provides leadership on major regulatory decisions, authority engagement models, and high-impact submissions, helping biopharmaceutical partners shape regulatory pathways and long-range development strategies. It advances clinical development through strategic regulatory planning, lifecycle management, and cross-functional collaboration. The consultant will work in a fast-paced, growth-oriented environment focused on strategic regulatory leadership and advancing clinical research. The role offers opportunities to learn and expand expertise across therapeutic areas and development phases.

Requirements

Bachelor's degree in life sciences, pharmacy, medicine, or a related field, or equivalent professional experience.
10 or more years of experience in regulatory affairs, clinical development, or a related field.
Previous experience with vaccine and/or biologic products.
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.
Strength in regulatory strategy, strategic planning, and cross-functional leadership.
Ability to lead across teams, influence stakeholders, and clearly communicate complex regulatory concepts.
Patient-focused mindset and strong attention to regulatory detail and compliance.

Nice To Haves

Advanced degree (M.D., Ph.D., or M.B.A.) or regulatory certification (e.g., RAC).
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.

Responsibilities

Own and develop regulatory strategy across significant programs or portfolios, aligning it with business objectives and regulatory requirements.
Provide leadership on major regulatory decisions, including authority engagement models, submission strategies, and risk mitigation approaches.
Lead 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 changes in the regulatory landscape and provide strategic recommendations to adapt development and submission approaches.