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3.0 - 5.0 years
0 Lacs
hyderabad, telangana, india
On-site
Summary Contributes and support the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Supports all registration activities of the Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment. About The Role Key Responsibilities Ensure procurement of various key regulatory components (e.g. ordering certificates, GMP, registration samples, COA's and other regulatory documents as per the needed) to achieve marketing authorization and life cycle maintenance in collaboration with following internal and external stakeholders: NTO, Reg CMC, Global labelling & RA Ops for renewals...
Posted 3 weeks ago
2.0 - 4.0 years
2 - 3 Lacs
Gurugram
Work from Office
Role & responsibilities Review and approve Finished Goods and corresponding Certificates of Analysis (COA). Maintain detailed records of received samples in an organized manner. Ensure proper allocation and storage of approved COAS in the shared drive. Verify and confirm drug product permissions as per regulatory requirements. Oversee the finalization of packing materials in coordination with relevant departments. Conduct audits of new vendors, ensuring compliance with quality standards. Ensure proper implementation of Corrective and Preventive Actions (CAPA) for any deviations or complaints. Visit manufacturing sites to address and investigate market complaints effectively. Coordinate with ...
Posted 3 months ago
2.0 - 5.0 years
2 - 3 Lacs
Gurugram
Work from Office
Role & responsibilities Review and approve Finished Goods and corresponding Certificates of Analysis (COA). Maintain detailed records of received samples in an organized manner. Ensure proper allocation and storage of approved COAS in the shared drive. Verify and confirm drug product permissions as per regulatory requirements. Oversee the finalization of packing materials in coordination with relevant departments. Conduct audits of new vendors, ensuring compliance with quality standards. Ensure proper implementation of Corrective and Preventive Actions (CAPA) for any deviations or complaints. Visit manufacturing sites to address and investigate market complaints effectively. Coordinate with ...
Posted 3 months ago
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