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Regulatory Affairs Specialist

3 months ago

Hoboken, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities
  • Responsible for the coordination and preparation of document packages for regulatory submissions from all areas of the Company.
  • Keeps abreast of regulatory procedures and changes.
  • Coordinates the collection of documents, records, reports, and data from the Development, Clinical Affairs, Quality, and Operations Departments for inclusion in regulatory documents.
  • ssists in the preparation of international registration dossiers for use in international registration by affiliates.
  • Participates with internal/external teams and builds professional relationships.
  • Identifies and suggests solutions to Regulatory tasks.
Requirements
  • Bachelor's Degree or equivalent
  • 5 years of related Regulatory Affairs experience.
  • bility to travel based on business needs.