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Amgen
Associate GRAAS OperationsAmgen • Hyderabad, India, IN
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Associate GRAAS Operations

Associate GRAAS Operations

Amgen • Hyderabad, India, IN
7 days ago
Job description
Job Description Role -GSIM Regulatory Data Management - Associate Organization - Global Regulatory Affairs Execution Team Team -Global Submission & Information Management (GSIM) Group Purpose -Ensure the smooth compliant flow of information between all Functional areas, internal and external to GRAAS, local offices, external partners and regulatory authorities. Job Summary - Monitoring data quality/health, including collaboration with other internal functions to maintain planned submission and approval dates - Integrations: - Updating the Regulatory Submissions and Document Information Management System (RSDIMS) and Analytics: - Metrics compilation and analysis - Liaison with internal customers to improve efficiencies within RDA and other functional areas - Manages requests within the Regulatory Intake System to comply with data management of a GMP system Key Activities - Maintain Regulatory document management and tracking systems - Create/archive Clinical Trial and Marketing Application submissions/Health Authority correspondence - Responsible for maintaining the on-site hard copy Regulatory archive and overseeing incoming/outgoing off-site Regulatory document storage - Point of contact between Regulatory Representatives/CMC and publishing teams - Manage the Protocol Amendment New Investigator (PANI) submissions and PI updates/additions - Ensuring Regulatory compliance with SOPs and Regulatory authorities - Provide support to RDA team members and other functional areas, including vendors - Collaboration with external partners/outsourced CROs - Manage 1572 forms for FDA submission Knowledge And Skills - Working in teams - Minimal familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance - Basic understanding of the Veeva Vault system - Good written and verbal communication skills and detail oriented - Independent time management and prioritization skills - Ability to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy, and respect - Critical thinking skills - Appropriate software skills as required Education & Experience (Basic) Bachelor's degree OR Associate's degree & 4 years of directly related experience OR High school diploma / GED & 6 years of directly related experience Education & Experience (Preferred) - Experience in an operationally focused role within Regulatory Affairs
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Associate GRAAS Operations • Hyderabad, India, IN

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