Regulatory Affairs Consultant - Clinical Regulatory Affairs

Parexel • Southport, NC

22h

About The Position

At Parexel, the goal is to improve the world's health by helping patients get access to life-changing therapies faster. As a Regulatory Affairs Consultant in a dedicated client partnership, you will play a critical role in guiding complex clinical studies through the regulatory landscape with rigor, insight, and collaboration. This high-impact opportunity is for a regulatory professional who enjoys ownership, visibility, and close partnership with clients. You will serve as the primary regulatory expert across multiple clinical studies, working closely with cross-functional teams and client stakeholders to ensure compliant and efficient trial execution. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the life sciences industry, with a proven track record spanning over 40 years.

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
• Knowledge of FDA Regulations and previous experience with FDA meeting requests and other packages
• 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

Nice To Haves

• Advanced degree strongly preferred
• Experience with other global Health Authorities and applicable regulations are strongly preferred

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
• Number of Employees: 5,001-10,000 employees