- Providing technical inputs to I&D, on review of CMC data for Central (DCGI) and State dossiers related to new product developments in the pipeline. - Reviewing and approving the content of I &D generated documents in Darius (a common database for stakeholders approval). - Harmonizing and aligning the I &D dossier submission process as per the local requirements by creation of standard CMC templates and checklists for submission. - Authoring scientific arguments and bridging the gaps on the queries from health authorities. - Compiling ACTD dossiers and authoring CMC documentation for successful filing of the products in the emerging markets. - Providing regulatory support for site related GMP audits for filings in emerging markets. - Mapping regulatory requirements for emerging markets and helping business teams with dossier gap analysis for evaluation of the product portfolio. Liaison with other departments such as I&D, quality, Supply chain to deliver high quality dossiers, in accordance with business priorities and maintaining sound working relationships with partners and customers.

Mumbai

Manager - Regulatory Affairs - Pharma 

Manager - Regulatory Affairs - Pharma  ,Job Description for Manager - Regulatory Affairs - Pharma  in Spectrum Talent Management in  Mumbai for (5-12) years of experience. Apply Now!

Job Description for Manager - Regulatory Affairs - Pharma  in Spectrum Talent Management in  Mumbai for (5-12) years of experience. Apply Now!