Senior Regulatory Affairs Specialist

Job Title:         Senior Regulatory Affairs Specialist

Coordinates collection of information and documentation and compiles into submissions, license renewals, periodic updates and registrations to regulatory agencies worldwide. Organizes regulatory information and logs, tracks and controls submissions.  Reviews and advises on labeling, protocols, development and manufacturing documents  for compliance with regulatory requirements.  Reviews and advises on product changes for impact on regulatory filings worldwide.  Researches regulatory issues and provides guidance and advice to colleagues. Reviews complaints for incident reporting.

Specific Responsibilities:

  • Collect and coordinate information to prepare regulatory documentation packages for review and submission to regulatory agencies or to our commercial partners.
  • Compile materials for license renewals, updates and registrations.
  • Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners.
  • Review labeling for compliance with regulatory requirements.
  • Reviews and advises on manufacturing batch records, product specifications, validation reports and other DHF records to ensure compliance.
  • Maintain current knowledge of international regulation, guidance and standards applicable to Anika products.
  • Research regulatory issues and disseminate regulatory information to Production, QA,QC and R&D departments and senior management.
  • Review complaints for potential MDR, MDPR, and vigilance reporting.
  • Review DCRs and Change Controls for regulatory compliance and possible submission.
  • Stay current on changes in regulations and agency guidance.

Job Complexity:

Exercises judgment within defined procedures. Works on problems of moderate to diverse scope.  Normally receives general instructions on routine work, detailed instruction on new assignments.

Experience, Knowledge, and Skills Required:

  • Requires BA degree in a health, science or related field or relevant experience
  • 5 to 7 years regulatory compliance experience in commercial environments
  • International experience is a plus
  • Requires creative, problem-solving ability and excellent oral and written presentation skills.
  • Requires proficiency with standard software (Word, Excel, PowerPoint, Project, etc.).
  • Excellent written and verbal communication skills

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