Regulatory Affairs Consultant - Regulatory Generalist

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 a highly organized, collaborative Regulatory Affairs Consultant - Generalist to provide end-to-end regulatory support for a strategic pharmaceutical partnership and its development and commercial programs. This role offers the opportunity to contribute across the regulatory lifecycle, from IND maintenance and health authority interactions through NDA submissions and post-approval commitments.

Working at the center of cross-functional and alliance teams, you will translate regulatory strategy into well-coordinated, high-quality deliverables. You will combine hands‑on Module 1 authoring and submission management with regulatory intelligence, health authority meeting support, lifecycle maintenance, documentation governance, and Global Regulatory Team coordination. The ideal candidate brings strong U.S. regulatory execution experience, sound judgment, and the ability to keep complex activities moving across multiple assets and stakeholders.

• Lead or support authoring, assembly, quality review, and submission management for IND Module 1 content and other U.S. administrative submission components.
• Maintain detailed tables of contents and submission trackers to provide visibility to content ownership, status, dependencies, approvals, and publishing readiness.
• Coordinate with regulatory publishing, document management, asset management, and subject matter experts to deliver complete, accurate, and timely submission packages.
• Draft and coordinate FDA forms, cover letters, submission metadata, and supporting administrative documentation.
• Manage review and approval workflows, resolve content or formatting gaps, and oversee handoffs through established publishing and submission processes.
• Support major regulatory submissions, including INDs, NDAs, supplements, amendments, and related health authority correspondence.

• Author and coordinate health authority meeting requests, briefing documents, meeting packages, and associated administrative components.
• Establish timelines, coordinate subject matter expert input, track reviews, and support finalization and submission.
• Coordinate FDA information request responses by engaging appropriate subject matter experts, consolidating content, and managing review cycles and timelines.
• Archive health authority correspondence and meeting records with accurate indexing, version control, and traceability.
• Ensure actions, commitments, and follow-up activities are documented and routed to the appropriate stakeholders.

• Prepare and coordinate IND and NDA lifecycle submissions, including protocol amendments, investigator updates, CMC amendments, Investigator’s Brochure updates, annual reports, supplements, and other regulatory maintenance activities.
• Author or coordinate applicable regulatory content for PADERs, PBRERs/PSURs, DSURs, Investigator’s Brochures, and…