Regulatory Affairs Consultant - Clinical Regulatory Affairs
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
#LI-LB1
#LI-REMOTE
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
#LI-LB1
#LI-REMOTE