- Regulatory Affairs Management- Global Labelling Management- Dossier Management- IVDR submission

- Responsible for the development, maintenance, and implementation of Company Core Data Sheets (CCDS) in line with international standards and guidelines.- Provide strategic and tactical labeling expertise to teams while ensuring compliance with applicable regulatory requirements.- Serve as the regulatory expert for labeling on the global Regulatory Affairs (RA) Sub team to ensure that regulatory labeling requirements are met for my assigned products. - Leads cross functional teams to update and ammend CCDS and other key global labeling documents i.e. ELTF (Extended Labeling Task Force)- Authors new/revised CCDS for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotation and supporting documentation- In coordination with Global Labeling Committee (GLC) Chair, manages review and approval of CCDS/resolution of labeling issues with the relevant GLC- Authors/manages outgoing communications to countries regarding significant labeling changes and CCDS changes for assigned products- Recommends strategies and labeling language for inclusion in key product labels (US PI, EU SmPC, JPI, others as appropriate), consistent with the overall product strategy and information in the CCDS, when available.- Provides labeling support and guidance to Country Regulatory Responsible (CRR), in collaboration with the RA Sub team.- Provides information and support during audits/inspections as a labeling subject matter expert.- Share knowledge on lesson learnt and impact within the team.- Represent as a core member of RA Sub-teams, and Safety Management Teams and for few Global program Team (GPT) for assigned products.- Interact with Country Regulatory Responsible (CRR) to ensure timely implementation of global labeling changes in local product information, and ensure international consistency and compliance with the core-data sheet.- Responsible for handling HA or CO labeling queries for assigned products.

-project manager for Medical device group-Established Medical device group at Novartis- Transition of medical device activity from Alcon Texas to Novartis Hyderabad-Managed resource and involved in recruitment, onboarding and year end appraisal- Worldwide submission of medical device (new submission and post approval submissions)

- Worked as program manager for new product development- involved in worldwide Regulatory submission strategy for new product launch.- Handled Renewals and CMC Variation & Production transfer activities for RoW markets- Utilized technical regulatory skills to propose strategies on complex issues -Handled the deficiencies letter of various HAs & CPOs of assigned countries within the time period.

Responsible for registration Certificates activity (tracking, ordering, follow up, receipt confirmation from Customer for administrative certificates i.e. CPP, GMP, TSE, Manufacturing Authorization certificate, Marketing Authorization Certificate etc.) from various health authority like (Swiss medic, USA FDA, Canada, Spain, Italy, Austria and UK etc.) for all countries across the Globe to ensure timely submission and approval for all pharmaceutical products and medical devices.-> Handled as Spanish translation coordinator and Coordinate the Spanish translation activities and provide all kind of support for dossier registration for all Spanish speaking Countries.Ensure excellent customer satisfaction and all requests are being handled in quick time with quality support. -> Support Novartis CPOs to provide justification or alternate solutions to enable quick submission of NCE, LE, LCM, CMC, PT, Renewal and New MA application to optimize the approval timelines.

Responsible for compilation, coordination and support of global regulatory submission for Sandoz under generic portfolio of Novartis (Rx-Gx) projects.-> Working in process enhancement/optimization for various activities for better productivity.Handled the deficiencies letter of various HAs & CPOs of assigned countries within the time period. -> Ensure excellent customer satisfaction and all requests are being handled in quick time with quality support. -> Support Novartis CPOs to provide justification or alternate solutions to enable quick submission of NCE, LE, LCM, CMC, PT, Renewal and New MA application to optimize the approval timelines. -> Mentoring interns in department.-> Preparing monthly report to reflect regulatory affairs activities.-> Arranged teleconference with various countries to resolve the various regulatory issues and updated the regulatory and product status to country.

-> Handled Regulatory submission for generic application (Compile, prepare, review and submit regulatory submission to authorities) for new registration, Renewals and variation dossiers to all LATAM, ME, China, Asia Pacific and CIS Countries & African clustures. -> Liaised with external and internal stakeholders for compiling the submission dossier to obtain data/documents & reviewed (Various TM & COA, STP, FP Spec & STP, Product Manual, Process Validation Protocol & Report, Batch Manufacturing Record and Batch Packaging record, Art works etc.) required in support of registration applications and to answer queries. ->Handled the deficiencies letter of various HAs of assigned countries within the time period. -> Maintained the dossier tracking submission for estimated and effective approval dates. And also courier consignment tracking list for all countries.-> Prepared import license and ensured all registration samples, working standard, reference standard and placebo for all products to reach in Health authority/country office for product registration/analysis purpose.->Arranged teleconference with various countries to resolve the various regulatory issues and updated the regulatory and product status to country.