POSITION SUMMARY:

This position will support regulatory activities related to investigational drug and biologic products. This position will participate in the compilation and production of various regulatory submissions according to timelines and in compliance with established submission standards, including eCTD requirements.

RESPONSIBILITIES:

• Compile and organize data and documentation for INDs as well as IND Amendments, Annual Reports, and General Correspondences
• Compile and organize data for Canadian Clinical Trial Applications and Amendments
• Prepare FDA Meeting Requests and Briefing Documents
• Review technical reports and submission documents relative to regulatory guidance requirements
• Review clinical documents relative to regulatory guidance requirements  
• Review change controls to determine regulatory impact and strategy
• Generate/review new and revised labeling components for global investigational products
• Review of non-promotional materials for investigational products and internal training materials to ensure compliance with Regulatory requirements
• Monitors, assesses, and maintains current awareness of evolving regulations and guidance documents
• Review and update standard operating procedures
• Other activities as assigned

SKILLS, EDUCATION AND EXPERIENCE:

• Bachelor’s degree required in Chemistry or Life Sciences
• Minimum of 3 years of related experience in the pharmaceutical industry, with specific experience related to the compilation, production and submission of regulatory dossiers in eCTD format
• Demonstration of positive interaction skills and work ethic
• Good communication skills (verbal and written)
• Good organizational skills and attention to detail
• Capable of working independently and in a team environment
• Ability to manage multiple tasks simultaneously
• Ability to successfully negotiate in a team environment
• Previous experience with Materials Review Committees preferred but not required
• Good skills with MS Word, Excel, PowerPoint, and Document Management Systems (e.g. SharePoint)

AVAILABILITY:

 Must be available to work extra hours, as required, to complete projects

LOCATION:

Position is located in Irvine, CA

Required Skills Required Experience