Compliance Specialist

1 week ago


St Petersburg, United States Mindlance Full time

Job Summary

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This role involves providing quality and regulatory affairs services, including Drug Master File (DMF) Updates, Health Authority GMP requests, processing customer product complaints; preparing annual product reviews, tracking and trending, and follow-up of Change Control and CAPA programs.

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Key Responsibilities:

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  • Preparation and submission of A/NDA submissions (initial, amendments, supplements, annual reports, 15-day Alert Reports); drug master files (initial, amendments, annual reports); plant/site master files; licenses, permits, and registrations to meet FDA and State requirements.">
  • Prepare and submit all federal, state and local permits in timely manner.">
  • Interact with Customers and gather information as required to support registration activities.">
  • Provide regulatory impact assessment on all change controls as required.">
  • Assist in the preparation of standard operating procedures (SOPs) associated with job function; review and approve SOPs requiring the regulatory function participation.">
  • Collaborate with Subject Matter Experts (SME)s, management and supervisory personnel from applicable areas to resolve problems affecting product quality.">
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About Mindlance

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Mindlance is a



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