Regulatory Affairs Officer
☞ KAISHA LIFESCIENCES PRIVATE LIMITED
View: 101
Update day: 06-05-2024
Location: Daman and Diu Union Territories
Category: Legal / Contracts
Industry: Pharmaceutical & Life Sciences
Position: Regulatory Affairs Manager
Job type: Full Time, Permanent
Experience: 1 - 4 years
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
Deadline: 20-06-2024
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