Regulatory Affairs Specialist

Company: Katalyst Healthcares & Life Sciences
Location: Cary
Posted on: January 26, 2023

Job Description:

Responsibilities:

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• Manages dossier compilation and publishing for assigned product(s) or projects in accordance with timelines established by Regulatory Affairs Licensing Product management to meet global registration objectives.
  
• Tracks and updates management regarding regulatory submission deliverables.
  
• Assembles, formats, publishes, and archives Regulatory registration dossiers/product development applications (e.g., BLAs, MAAs, NDSs, NDAs, PMAs, 510(k)s, INDs/CTAs, Orphan Drug Applications, etc.), and life-cycle management submissions (supplements, variations, amendments) for Canada, US, ICON/ROW and EU. Creates hyperlinks/cross-references/bookmarks, as necessary, within documents/dossiers.
  
• Assists in the drafting, implementation, and revision of internal regulatory business practices (IBPs) and procedures (SOPSs) pertaining to paper and electronic publishing and submission.
  
• Ensures compliance with regulatory agency rules and guidelines for paper and electronic submissions. Provides update to internal documentation, as appropriate. Prints paper dossier or burns CD/DVD for submissions, manages shipment (e.g., Fed Ex, DHL) and tracking of submissions.
  
• Responsible for data entry, filing, archiving and maintenance of submission tracking databases for all outgoing/incoming communication with regulatory agencies.
  
• Update tracking/notification databases and spreadsheets. Assists in piloting new submission platforms/tools, processes and/or formats.
  
  Requirements
  
  
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  • Ideally should have e-submissions and regulatory information management experience. Basic knowledge of applicable laws and regulations.
    
  • Familiarity with electronic regulatory publishing and submissions software. Superior skills with the use of MS-Word, Adobe Acrobat and Adobe plug-in tools.
    
  • Flexible and adaptable to changing situations within the company/industry. Ability to work independently with limited supervision.
    
  • High degree of attention to detail and troubleshooting skills. Ability to meet tight project timelines.
    

Keywords: Katalyst Healthcares & Life Sciences, Cary , Regulatory Affairs Specialist, Other , Cary, North Carolina