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US FOOD AND DRUG ADMINISTRATION, OFFICE OF REGULATORY AFFAIRS
United States - Nationwide
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Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois
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Spec, Regulatory Affairs II- San Juan Capistrano, CA (mostly remote)
Spec, Regulatory Affairs II- San Juan Capistrano, California - Monday to Friday JOB SUMMARY: With minimal supervision, responsible for coordination and preparation of document packages for regulatory submissions from all areas of the company. Compiles all materials required for submissions, license renewals and annual registrations to ensure the sale ability of Celera products domestically (United States) and internationally (EU/Canada/ROW). Reviews and recommends changes for labeling, marketing literature and clinical protocols for regulatory compliance to international/recognized stand
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