Clinical Regulatory Delivery Lead - eCTD Submissions

Jobtailor; Indianapolis (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

Jobtailor in Indianapolis, IN, seeks a regulatory operations professional to lead the registration management process, ensuring compliance with electronic submission regulations and global ICH standards. Collaborate across geographies and guide development teams on regulatory requirements for submissions.

The role requires expertise in CTD/eCTD structures, complex lifecycle submissions, and strong project management capabilities to drive end-to-end registration planning and execution.

Qualifications

• 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.
• 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.

Responsibilities

• 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

Skills

Regulatory Operations Experience

Project Management Experience

Knowledge of Drug Development Process

Experience with eCTD Submissions

Strong Knowledge of ICH Regulations

Education

BS or higher degree in chemistry, biology, pharmacy or life sciences

Tools

ECTDXpress

Veeva Platforms

Job description

Jobtailor in Indianapolis, IN, seeks a regulatory operations professional to lead the registration management process, ensuring compliance with electronic submission regulations and global ICH standards. Collaborate across geographies and guide development teams on regulatory requirements for submissions.

The role requires expertise in CTD/eCTD structures, complex lifecycle submissions, and strong project management capabilities to drive end-to-end registration planning and execution.