Administrative Assistant - Pharma

Responsibilities

• Maintain and archive both paper and electronic records in accordance with internal procedures to ensure complete and compliant regulatory files for each product.
• Perform data entry for regulatory projects, including work within Regulatory Information Management Systems (e.g., Veeva), Microsoft Office applications (Excel, Word), and Smartsheet.
• Support the finalization of job descriptions and standard operating procedures (SOPs), including routing for review, approval, signature, and appropriate filing.
• Prepare, submit, and archive FDA promotional and labeling submissions.
• Serve as the U.S. R&D Archivist, overseeing document management activities.
• Maintain the U.S. on-site document storage room.
• Manage the U.S. off-site storage vendor and track documents sent and received.
• Annually archive and transition off-site files older than five years.
• Support unblinded safety submissions, including DSURs, as needed.
• Provide support during audit preparation when required.
• Assist in the preparation of U.S. regulatory deliverables.
• Perform quality control reviews of U.S. regulatory submissions and internal documents.

Necessary Requirements

Educational Qualifications :

Professional Experience :

Professional Skills :

Specialized Skills :

Managerial / Operational Skills :