Job ID REQ-10032508 Dec 04, 2024 India Summary Provide advanced regulatory CMC operational, submission and compliance support to department in accordance with defined requirements to guarantee timely preparation of high-quality CMC regulatory submissions and associated compliance information throughout the life cycle. About the Role

Major accountabilities:

Independently, perform RA CMC compliance and operational support including QC check, DA checks, IND AR writing & coordination. CMC contact for some countries, compliance/regulatory database entry and reports and ensure appropriate eCTD operator attributes, module chaptersCreate CMC submission documentation such as folders structure, metadata forms, RA request forms, populating RA CMC tracking sheets, letters, and various Health Authority forms. Act as super-user, business data owner and data steward in the applicable Regulatory Information Management SystemProactively ensure CMC documentation is eCTD compliant and submission ready. Support eCTD compliance maintenance for the external documentation linked to the CMC submission modules, including third party documentationIndependently support CMC project teams for document finalization, ancillary documents coordination and source documents management. Coordinate, prepare, compile and track CMC submissions for delivery to RA Operations Support RA CMC project teams to handle Country Organization (CO) request in the RA CMC ticketing system, organizing submission coordination activities like source documents and ancillary documents collectionPerform super-user role of documentation system / support super-user for e.g. account requests / modifications as assignedActively participate as a member of the global RA CMC project teams by contributing to the project operational and compliance strategy, identifying the potential compliance issues and sharing lessons learnedAcquire and maintain GMP Certificates and Manufacturing Authorizations required for RA CMC submission in the Document Management SystemCoordinate preparation of declarations required for submission in RoW countriesSupport other GSOC team members in leading various operations, compliance, Data & Digital initiatives

Key performance indicators:

High quality regulatory submissions and operational documentationTimeliness of deliverables: No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate CMC documentation and compliance support on matters within RA CMC controlProactive and accurate information / communication about operational and compliance issues within own department and to key stakeholdersIndependently ensure that the operational activities and CMC regulatory documentation follow Novartis and eCTD guidelines. Regulatory compliance met in all compliance systemsBuild and maintain collaborative partnerships with stakeholdersPartner with other GSOC team members to ensure business continuity

Minimum Requirements:
Work Experience:

Preferably 3 years in regulatory submission management.Working experience in pharma industry data systems, data and submission managementAbility to work successfully with global project teams and prioritize activities considering timelines and workloadEffective planning, organizational and interpersonal skillsPrior submission management/publishing experience desiredComputer literacy/IT systems literacy: Excellent data processing skills with current operating systems

Skills:

Documentation Management.Project ExcellenceDigital & Data savvyInterpersonal SkillsOperational Excellence.Regulatory Compliance.

Languages:

English.

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Division Development Business Unit Innovative Medicines Location India Site Hyderabad (Office) Company / Legal Entity IN10 (FCRS = IN010) Novartis Healthcare Private Limited Functional Area Research & Development Job Type Full time Employment Type Regular Shift Work No Apply to Job Accessibility and accommodation

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