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.

• Global Standards:
  Deep dive into the ICH (International Council for Harmonisation) guidelines.
• Software Proficiency:
  Exposure to industry-standard tools like Veeva Vault.
• 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.