Intern- Regulatory Affairs

As a Regulatory Affairs Operations Intern, you will support the lifecycle management of global regulatory submissions, including ensuring the submissions are formatted correctly, tracked accurately, and submitted on time.

What You Will Learn:

Global Standards: Deep dive into the ICH (International Council for Harmonisation) guidelines.
1. Software Proficiency: Exposure to industry-standard tools like Veeva Vault.
2. Regulatory Strategy: A high-level view of how a drug moves from the lab to the patient through the lens of compliance.

• Electronic Document Preparation: Assist in the formatting and "publishing" of documents to ensure they meet eCTD (Electronic Common Technical Document) standards.
• Submission Tracking: Maintain internal databases and Regulatory Information Management (RIM) systems to track the status of global filings and approvals.
• Quality Control (QC): Perform rigorous checks on hyperlinks, bookmarks, and metadata within electronic dossiers to prevent technical rejections from health agencies.
• Project Coordination: Help manage submission timelines by coordinating with cross-functional teams (Clinical, Quality, and Supply Chain) to collect necessary documentation.
• Archive Management: Assist in the digital archiving of correspondence with health authorities and final submitted sequences.

• Currently pursuing a degree in Life Sciences (Biology, Chemistry, Pharmacy), Health Informatics, or a related technical field.
• Prior work experience with preference given to past experience or internships in Pharmaceutical industry.
• High proficiency in Microsoft Word and Adobe Acrobat (specifically using "toolbox" plug-ins) is essential.
• Extreme attention to detail
• An interest in how software and standardized workflows can improve speed and compliance.