Regulatory Associate (Cmc), Submission Management And Publishing Support

Overview

• Support regulatory submission management activities, ensuring timely and compliant Health Authority submissions.
• Collaborate with cross-functional teams and external vendors for submission coordination.
• Prepare dossiers for electronic submissions, adhering to global regulatory standards.
• Maintain regulatory documentation and records in compliance with internal procedures.
• Perform quality checks on regulatory documents to ensure accuracy and completeness.
• Contribute to the development and maintenance of submission-related tools and templates.
• Assist in tracking submission milestones and preparing status updates.
• Provide support for the assembly and publishing of eCTD submission components.

Key Responsibilities & Duties

• Coordinate and execute regulatory submissions, including INDs, IMPDs, amendments, and annual reports.
• Compile submission content and ensure timely deliverables from contributors.
• Prepare regulatory documents for electronic submission, ensuring technical compliance.
• Perform quality checks on submission documents, including bookmarks and hyperlinks.
• Maintain regulatory documentation in relevant systems and repositories.
• Support the maintenance of submission archives and communication records.
• Assist in developing departmental tools and templates for submission management.
• Collaborate with internal teams and vendors for publishing and quality control.

Job Requirements

• Bachelor’s degree in life sciences, Regulatory Affairs, or related field required.
• 2–5 years of experience in Regulatory Affairs, with electronic submission support preferred.
• Familiarity with eCTD structure, publishing processes, and submission-ready document requirements.
• Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint.
• Experience with Veeva RIM or similar regulatory information management systems preferred.
• Strong organizational skills and ability to manage multiple tasks and deadlines.
• Excellent attention to detail and commitment to document quality and accuracy.
• Ability to work effectively in a cross-functional, fast-paced environment.