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.

What You'll 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 expectations and agreed timelines
• Support ad hoc study needs and contribute to continuous improvement and departmental initiatives

To Ensure Success, You'll Have

• 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

Why Join Parexel?

• 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

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