U.S. Regulatory Strategists; Senior Regulatory Affairs Associate​/Consultant

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart®.

We are seeking experienced U.S. Regulatory Strategists at the Senior Regulatory Affairs Associate and Regulatory Affairs Consultant levels to join our team in a remote capacity. As a U.S. Regulatory Strategist, you will support and execute U.S. regulatory strategies for vaccine and biologic programs across development, registration, and post-approval lifecycle activities. Your work helps bring new vaccines and biologic therapies to patients in the United States and advances clinical research.

This position plays a key role in U.S. regulatory strategy, FDA interactions, regulatory submissions, and labeling and lifecycle compliance. You will collaborate with global regulatory and cross‑functional teams, apply strong knowledge of FDA requirements, and contribute to regulatory decisions from planning through post‑approval activities. Responsibilities include U.S. regulatory strategy development, FDA interactions, regulatory submissions, global regulatory collaboration, labeling and lifecycle management, regulatory intelligence, and cross‑functional collaboration, with opportunities to deepen your expertise and influence regulatory outcomes.

You’ll join a fast‑paced, growth‑oriented environment focused on making a meaningful impact through strategic U.S. regulatory support, timely and compliant FDA submissions, and close partnership with global regulatory and cross‑functional teams. With diverse teams and continuous learning opportunities, as a U.S. Regulatory Strategist you can explore different career paths and expand skills across regulatory affairs and clinical research.

• Develop, support, and execute U.S. regulatory strategies that align with global development, registration, and lifecycle management plans.
• Support or lead FDA interactions, including meeting preparation, responses to agency questions, regulatory issue resolution, and management of commitments.
• Plan, coordinate, review, and support the execution of U.S. regulatory submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologics License Applications (BLAs), supplements to NDAs and BLAs (sNDAs and sBLAs), and post‑approval submissions.
• Represent U.S. regulatory requirements and perspectives within global regulatory teams, contributing to regulatory strategy, submission planning, and decision‑making.
• Support U.S. Prescribing Information, labeling updates, regulatory compliance, and post‑approval activities.
• Monitor and interpret evolving FDA regulations, guidance documents, and policies, and assess their potential impact on assigned programs.
• Partner with Clinical, CMC (Chemistry, Manufacturing, and Controls), Safety, Medical, Commercial, and global Regulatory teams to ensure timely and compliant regulatory deliverables.

You’ll thrive in this role if you bring:

• Practical U.S. regulatory strategy experience and direct FDA exposure
• The ability to operate effectively within a global…