Regulatory Affairs Specialist

• Plan/author/compile/submit statutory reports in eCTD format for marketed products per FDA requirements
• Assist with CMC regulatory impact regulatory strategy for post-approval changes proposed at the manufacturing site
• Preparation information and technical data needed for support of post-approval changes
• Author/review updates to marketed product labeling
• Maintain regulatory knowledge of current guidelines and regulations
• Maintain current regulatory databases and produce various reports as needed
• Utilize and support electronic document management system
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)
• Authoring, organization, and preparation of electronic (eCTD) regulatory filings
• also includes peer review of filings
• Assist with identification of potential regulatory risks and recommended strategies based on current FDA/health authority requirements
• Manage multiple priorities
• Attend necessary trainings and seminars to keep abreast of new and/or changes in the Regulatory profession
• Critically review documentation for regulatory submissions and provide input for necessary revisions

• Bachelor Degree in scientific discipline required or equivalent work experience
• Minimum of 1-2 years of Regulatory experience or related field
• Cross functional interaction experience, coordinating activities, driving projects and initiatives to completion, and working to align communications with other departments is required
• Project leadership or supervisory experience is preferred
• Strong organizational skills, strong attention to detail, ability to problem solve and to work well with others and cross-functionally
• Excellent written and oral communication skills
• Use of change controls software system
• Strong background using Microsoft Office tools and Adobe Acrobat

Project leadership or supervisory experience