Position: Regulatory Affairs Manager

Job type: Full Time, Permanent

Experience: 1 - 4 years

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Job content

Roles and Responsibilities

  • Preparation and Submission of Dossiers (CTD/e-CTDs/ACTD/Country Specific format) ensuring timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
  • Responsible for handling the queries related to the Dossiers
  • SOP preparation and documentation for handling of Regulatory work.
  • Maintain current knowledge of relevant regulations, including proposed and final rules.
  • Manage activities such as audits, regulatory agency inspections, or product recalls.
  • Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
  • Establish procedures or systems for publishing document submissions. Etc

Vacant Position:Regulatory Affairs Officer




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Deadline: 20-06-2024

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