Legal Regulatory Affairs

3 - 7 years

2 - 4 Lacs

Posted:1 week ago| Platform: Naukri logo

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Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

1. Responsible for preparing draft legal documents and applications, coordinating with concerned departments, and ensuring all drafts met statutory and regulatory requirements

2. Apply Product Permission,

3. Apply COPP (Certificate of Pharmaceutical Product)

4. Apply FSC (Free Sale Certificate)

5. Responsible for the preparation, review, and submission of manufacturing licence applications, ensuring all required documentation was accurate, complete, and compliant with regulatory and statutory requirements.

6. Responsible for the preparation, review, and submission of WHO GMP certificate applications, ensuring all required documentation was accurate, complete, and compliant with regulatory and statutory requirements.

7. Responsible for the preparation, review, and timely submission of applications for Export No Objection Certificate (NOC) from Central Drugs Standard Control Organization (CDSCO).

8. Managed and maintained basic legal sheets by tracking legal documents, monitoring validity and renewal dates, and ensuring records were accurate and well-organized.

9. Sample Packing, tracking courier details for documents and samples

10. Review and correction in DMF

11. Preparation of SMPC, Insert and draft artwork text matter.

12. Assist in any task allotted by seniors.

13. Coordinate with internal teams for the hassle free preparation of dossiers and executing sample activities.

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