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Job Location | Chennai |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Pharma / Biotech |
Functional Area | General / Operations Management |
EmploymentType | Full-time |
Functions as the primary CMC strategist & reviewer for the Life Cycle Management (LCM) activities of assigned products and/or projects providing regulatory assessments and developing regulatory strategies for global markets including US/EU/APAC/LATAM & AfME regions; Accountable for assigned projects and activities, completing work within assigned product portfolio. Develops resolution proposals for regulatory CMC issues with the stakeholders.Reviews proposed CMC changes for completeness and accuracy, interpret CMC regulatory requirements , develops strategies, assess risks and develops contingency proposals. Use technical and scientific knowledge to conduct the analysis of CMC submission documentation.Responsible for the authoring of CTD sections (Module 3 and QOS) and review of CMC documentation, coordination and management of global submissions, including the assessment and management of commercial license status, maintenance of product compliance and management of change control; Management of Queries; Works almost independentlyJob Responsibilities: Functions as an experienced CMC Strategist responsible for development and execution of regulatory strategies for the submissions and compliance activities of assigned products; Collaborates with Cross Functional Teams (RRHS/PCO/RCM/Site CNM) and GRS-CMC to ensure the deliverables. Has advance knowledge/understanding of the principles and concepts of the process being followed, to perform the below listed activities but not limited to :
Keyskills :
salesmarketingbusiness developmentmanagementbudgetinghandle multiple projectsequal employment opportunityenvironmental impact assessment