Clinical Regulatory Associate, GRA Regulatory Delivery Excellence

• Lead the registration management process by providing expertise in electronic submission regulations and guidance
• Partner with other geographies to understand and incorporate local agency regulations and requirements
• Guide and influence development team and function regarding internal and Agency registration management processes and requirements
• Own the registration management process at the molecule/project level
• Serve as the RDE operational lead for registration planning and execution
• Own the routine compliance submissions and processes
• Partner with the Regulatory Coordinator/Scientist to drive execution of the product deletion, IND inactivation/withdrawal process
• Provide registration management expertise to due diligence processes

• BS or higher degree in a technical field such as chemistry, biology, pharmacy or life sciences
• Qualified applicants must be authorized to work in the United States on a full-time basis
• Knowledge of drug development process
• Project Management Experience
• Previous experience working in the Pharmaceutical industry
• Experience with CTD/eCTD structure and format
• Experience using eCTD compliant publishing system (eCTDXpress or Veeva based platforms)
• Three years of regulatory operations experience within a regulated environment
• Experience with Original IND and supplemental NDA/BLA eCTD submissions including complex lifecycle submissions
• Strong knowledge of global health authority and ICH regulations

Demonstrates expertise in registration management processes, including electronic submission regulations and compliance within the pharmaceutical industry. Proficient in project management and collaboration with cross-functional teams to ensure adherence to global health authority and ICH regulations.

• Regulatory Operations Experience
• Project Management Experience
• Knowledge of Drug Development Process
• Experience with eCTD Submissions
• Strong Knowledge of ICH Regulations

• Regulatory Management
• ECTD Submission
• IND Submission
• NDA Submission
• Project Management
• Drug Development Knowledge
• Compliance Processes
• Registration Planning
• Lifecycle Submissions
• Due Diligence Processes

• Pharmaceutical Industry
• Global Health Authority Regulations
• ICH Regulations
• Electronic Submission Regulations
• Registration Management

• ECTDXpress
• Veeva Platforms