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
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
Manage regulatory communication strategy for assigned studies
Participate in regular study team meetings to track trial progress and proactively surface regulatory considerations
Maintain accurate, current regulatory tracking systems in accordance with Parexel and client standards

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.

Regulatory Affairs Consultant – Clinical Regulatory Affairs

Key skills