Regulatory Affairs Consultant

Responsibilities

• Develop and execute regulatory strategies for clinical development programs
• Lead health authority interactions and manage regulatory submissions, including IND applications, annual reports, and safety submissions
• Conduct regulatory impact assessments and risk analysis
• Provide regulatory expertise on complex compliance issues
• Serve as the regulatory authority within cross-functional teams
• Ensure adherence to ICH guidelines and global regulatory pathways

Requirements

• Minimum 5+ years of experience in regulatory affairs
• Demonstrated expertise in health authority strategy and regulatory submissions
• Strong knowledge of clinical development regulations and ICH guidelines
• Proven experience with IND applications, annual reports, and safety submissions (e.g., IND 120, IND 130)
• Familiarity with electronic submission systems (e.g., e-STARs)
• Bachelor’s degree in a scientific or technical discipline (advanced degree strongly preferred)
• Knowledge of FDA Regulations and experience with FDA meeting requests

Preferred Qualifications

• Experience with other global Health Authorities and applicable international regulations

About the Company

Parexel is a global leader in clinical research, driven by a single purpose: to partner with clients and help patients get access to life-changing therapies faster. We offer a supportive, inclusive, and flexible remote work environment where professionals can grow through challenging assignments and mentorship from industry experts.