Regulatory Affairs Consultant - Clinical Regulatory Affairs

Parexel • Southport, NC

2d

About The Position

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. 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, you’ll 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. You’ll 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.

Requirements

• At least 5 years of regulatory affairs experience to include previous clinical regulatory affairs experience
• A minimum of a bachelor’s degree in a scientific or technical discipline, advanced degree strongly preferred
• Knowledge of FDA Regulations and previous experience with FDA meeting requests and other packages.
• Experience with other global Health Authorities and applicable regulations are strongly preferred
• Project management / leadership experience
• Excellent interpersonal and intercultural communication skills, both written and verbal
• Client-focused approach to work (Quality)
• Results orientation
• Teamwork and collaboration skills
• Consulting skills
• Critical thinking and problem-solving skills
• Proficiency in local language and extensive working knowledge of the English language

Responsibilities

• 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
• 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
• 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
• Maintain accurate, current regulatory tracking systems in accordance with Parexel and client standards
• Ensure all regulatory documentation meets quality expectations and agreed timelines
• Support ad hoc study needs and contribute to continuous improvement and departmental initiatives

Benefits

• Work in a dedicated partnership model with strong client trust and visibility
• Be part of a global organization known for regulatory leadership and scientific excellence
• Collaborate with talented, purpose‑driven colleagues across functions and regions
• Make a meaningful contribution to clinical programs that put patients first

What This Job Offers

• Job Type: Full-time
• Career Level: Senior