Regulatory Affairs Executive (DRA)
Published date: 2024/01/10
- Location: Mumbai, Maharashtra, India
Qualifications
Bachelor's (Preferred)
Total work: 4 years (Preferred)
Full Job Description
REQUIRE SENIOR EXECUTIVE – DRA
1. To prepare Country specific dossiers in the format of CTD/ACTD and specific formats as per the respective countries guidelines
2. Co-ordination with third party manufacturing facility . Collecting documents from third party manufacturers.
3. To provide artwork text matter for preparing product label artworks.
4. Follow-up for FDA licenses/COPP applications
5. Responding to queries raised by MOH.
6. Coordinate with plants to get the Dossiers/ Technical documents and samples of products for registration.
7. To prepare raw data for the dossier.
8. To fill the tender forms & providing requested documents
9. Maintaining the registration data base country wise – registered and Under registration
10. Export COA’s as per registered Specification
11. Courier Documents for export.
12. To do legalization documentation as per country requiremen
Job Type: Full-time
Bachelor's (Preferred)
Total work: 4 years (Preferred)
Full Job Description
REQUIRE SENIOR EXECUTIVE – DRA
1. To prepare Country specific dossiers in the format of CTD/ACTD and specific formats as per the respective countries guidelines
2. Co-ordination with third party manufacturing facility . Collecting documents from third party manufacturers.
3. To provide artwork text matter for preparing product label artworks.
4. Follow-up for FDA licenses/COPP applications
5. Responding to queries raised by MOH.
6. Coordinate with plants to get the Dossiers/ Technical documents and samples of products for registration.
7. To prepare raw data for the dossier.
8. To fill the tender forms & providing requested documents
9. Maintaining the registration data base country wise – registered and Under registration
10. Export COA’s as per registered Specification
11. Courier Documents for export.
12. To do legalization documentation as per country requiremen
Job Type: Full-time
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