Regulatory Affairs Consultant - Clinical Regulatory Affairs

at Parexel in Boise, Idaho, United States

Putting Patients First-Through Regulatory Excellence

At Parexel, we are driven by a single purpose: to help patients get access to life-changing therapies faster. As a Regulatory Affairs Consultant in a dedicated client partnership, youll play a critical role in making that mission real-guiding complex clinical studies through the regulatory landscape with rigor, insight, and collaboration.

This is a high-impact opportunity for a regulatory professional who enjoys ownership, visibility, and close partnership with clients. Youll serve as the primary regulatory expert across multiple clinical studies, working shoulder-to-shoulder with cross-functional teams and client stakeholders to enable compliant, efficient trial execution.

If you thrive in a consultative environment, value strong relationships, and want your work to directly support clinical progress, this role offers the best of Parexel: scientific depth, global reach, and true partnership.

What Youll Do:

Regulatory Strategy & Compliance

+ Serve as Regulatory Affairs Lead for 5+ clinical studies within a dedicated client team

+ Provide strategic regulatory guidance to cross-functional study teams navigating complex and evolving global requirements

+ Assess regulatory impact of protocol amendments, informed consent form ( ICF ) updates, and other study changes

+ Determine whether updates are substantial or non-substantial in accordance with applicable regulations

+ Advise teams on regulatory pathways, processes, and solutions for emerging trial issues

Health Authority Engagement

+ Plan, coordinate, and author health authority meeting requests and scientific advice packages, as required

+ Lead preparation and coordination of responses to health authority questions and requests for information

+ Manage regulatory communication strategy for assigned studies

+ Ensure timely and compliant submission of annual reports and safety updates

Stakeholder Partnership & Communication

+ Participate in regular study team meetings to track trial progress and proactively surface regulatory considerations

+ Provide clear and accurate updates to client management on regulatory status, risks, and upcoming milestones

+ Act as the primary regulatory point of contact for study teams and client stakeholders

Documentation & Project Management

+ Maintain accurate, current regulatory tracking systems in accordance with Parexel and client standards

+ Ensure all regulatory documentation meets quality expectati