Regulatory Associate

Hybrid Details: 3 days/week onsite

Duration: 5 months to start



Job Summary:
The Regulatory Associate is responsible for supporting regulatory submission management activities, pre-publishing, and the maintenance of regulatory documentation to ensure timely, accurate, and compliant Health Authority submissions. This role works cross-functionally with Regulatory Affairs and external publishing vendors to coordinate submission components, prepare dossiers for electronic submission and maintain regulatory records in accordance with internal procedures and global regulatory requirements.



Key Responsibilities

Submission Management Support

• Support the planning, coordination, and execution of regulatory submissions, including INDs, IMPDs, amendments and annual reports, as applicable.
• Assist with the compilation of submission content and ensure deliverables are received from functional contributors according to established timelines.
• Track submission milestones, deliverables, and dependencies to support on-time execution.
• Assist in preparing submission-related trackers, timelines, and status updates for internal stakeholders.

Pre-publishing and Publishing Support

• Prepare regulatory documents for publishing by ensuring they meet technical and formatting requirements for electronic submission.
• Perform pre-publishing quality checks, including verification of bookmarks, hyperlinks, document properties, table of contents and file naming conventions.
• Support assembly of eCTD submission components in collaboration with internal teams and/or external publishing vendors.
• Conduct quality control reviews of published submission output to ensure completeness, accuracy and compliance.

Regulatory Documentation and Records Maintenance

• Maintain regulatory documentation in document management systems, regulatory information management systems, and shared repositories, as applicable.
• Support maintenance of submission archives, correspondence logs, health authority communication records and regulatory trackers.
• Support the maintenance work instructions, templates, and departmental tools related to submission management and publishing activities.

Qualifications

Education

• Bachelor's degree in life sciences, Regulatory Affairs, or a related discipline required.

Experience

• 2-5 years of experience in Regulatory Affairs
• Experience supporting electronic regulatory submissions and document preparation in a regulated environment preferred.
• Familiarity with eCTD structure, publishing processes, and submission-ready document requirements preferred.

Required Skills and Competencies

• Strong organizational skills and the ability to manage multiple tasks and deadlines simultaneously.
• Excellent attention to detail and commitment to document quality and accuracy.
• Understanding of regulatory submission processes and document lifecycle management.
• Ability to work effectively in a cross-functional, fast-paced environment.
• Strong written and verbal communication skills.
• Proficiency in Microsoft Office applications, including Word, Excel, Outlook, and PowerPoint. Proficiency in Veeva RIM preferred.
• Ability to identify issues proactively and support timely resolution.
• Demonstrated ability to maintain confidentiality and handle sensitive documentation appropriately.

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