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

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Sr Regulatory Coordinator Novartis India

3.0 - 5.0 years

0 Lacs

hyderabad, telangana, india

On-site

Summary The Senior Regulatory Coordinator (Sr. RC) works under close supervision to support for development including line extension and /maintenance projects through development, registration, and approval including post approval commitments. To maximize operational effectiveness, Collaborate with RA GDD Development Units, RA GDD CMC, Regional Representatives (MoW, LACan, EU, China, Japan), Novartis Technical Operations (NTO), and Quality Assurance to align on planning, execution, communication, and completion of assigned projects. About The Role Key Responsibilities Ensure procurement of various key regulatory components (e.g. ordering certificates, GMP, registration samples, COAs and othe...

Posted 2 months ago

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Sr Regulatory Coordinator Novartis India

3.0 - 5.0 years

0 Lacs

Hyderabad, Telangana, India

On-site

Posted 3 months ago

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