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Job Location | Bangalore |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Pharma / Biotech |
Functional Area | General / Other Software |
EmploymentType | Full-time |
Job Title: Associate Manager I Product Regulatory AffairsLocation: Bangalore GCL: D2Description:The Associate Manager I are a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned results, including delivery as an individual contributor, if required. The Associate manager I may take on the accountabilities for a number of different roles within a Global Regulatory Execution Team (GRET): Regulatory Project Management, Global Labelling Management and Dossier Management. The Associate Manager I are expected to be able to work flexibly to deliver these varied accountabilities as assigned to them by their line manager or by the Lead Regulatory Project Manager (RPM) for their allocated GRET(s).The Associate Manager I are fully proficient in applying established standards to perform regulatory project management for simple/moderately complex products/regions and under minimal direction. Capable of leading cross-functional activities. Participates continuous improvement of process and tools/systems.Regulatory Project ManagementContributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. Provides regulatory expertise and guidance on procedural and documentation requirements to GRET, Global Regulatory Strategy Team (GRST) and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.Global Labelling ManagementProvides regulatory labelling expertise and leadsto the maintenance of global labelling documents for allocated products. Is responsible for the regulatory activities involved in the coordination, development and implementation of revised printed labelling for allocated products, including USPIs and another regional labelling.Dossier ManagementPlans and manages Regulatory and basic Clinical and Non-Clinical publishing results, as well as associated lifecycle and license information. Collaborates with publishing teams to assure efficient delivery of end to end submission output to project timelines.Accountabilities/Responsibilities:Regulatory Project Management
Keyskills :
project managementproject planningcustomer relationsmanagementcorporate liaisonknowledge sharingcore datamissalesversion controlregulatory issuesqualitystatements of work sow