Job Description

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:

• Bachelor’s Degree in Life Sciences (minimum)

Professional Experience:

• At least 2 years of administrative support experience, preferably within a scientific or regulatory environment

Professional Skills:

• Strong communication skills
• Ability to manage multiple tasks simultaneously
• Exceptional attention to detail
• High productivity and efficiency

Specialized Skills:

• Understanding of pharmaceutical regulations and regulatory processes
• Strong knowledge of process analysis and optimization tools and methods

Managerial/Operational Skills:

• Effective decision-making
• Strong planning and execution abilities
• Ability to drive results and meet deadlines

Job Tags

Similar Jobs