Manager of Regulatory Affairs, Consultant

📋 Description

• Contribute to the development and execution of regulatory strategies aligned with organizational
• Coordinate and manage the preparation, review, and submission of regulatory documentation
• Prepare and coordinate responses to regulatory questions and requests, ensuring timely, accurate
• Ensure regulatory documents comply with applicable global guidelines, ICH standards, and regional
• Collaborate with Quality Assurance and Regulatory Affairs colleagues to support GxP compliance
• Partner with Clinical, Clinical Operations, Quality Assurance, Manufacturing, Nonclinical, and

🎯 Requirements

• Bachelor's degree or advanced degree in a relevant scientific discipline.
• Approximately 2–5 or more years of Regulatory Affairs experience within the biotechnology or
• Strong understanding of global and regional regulatory requirements, ICH guidelines, and evolving
• Experience supporting regulatory activities for cell therapy or gene therapy products.
• Familiarity with CTD/eCTD documentation, regulatory submissions, and product lifecycle management.
• Ability to prepare, review, and coordinate complex regulatory documents while ensuring

🎁 Benefits

• Competitive hourly compensation: $75–$85 per hour, depending on experience and qualifications.
• Remote flexibility: Work remotely from the United States, with a preference for candidates able to
• Defined contract duration: Six-month consulting opportunity with a full-time schedule of
• Meaningful scientific impact: Contribute to the development of innovative cell therapies targeting
• Cross-functional collaboration: Work alongside experienced professionals across regulatory
• Professional development: Gain exposure to complex regulatory strategies, global submission