Specialist - RA
HybridMumbai, Maharashtra, India
EXPIREDMumbai, Maharashtra, IndiaHybridFull TimeEnterprise
Full TimeEnterprise
Job Summary
Manage medium to small global regulatory submission projects and contribute to technical regulatory strategy for developing and maintaining global products. Interpret and enforce documentation formatting standards, policies, and operating procedures while ensuring compliance with regulatory agency requirements. Maintain technical and non-technical documentation change systems, classify records, and coordinate the assembly of regulatory dossiers. Analyze data to extract pertinent information and prepare executive summaries of material searched, reporting technical complaints or adverse events within 24 hours of receipt.
Required Qualifications
- Cross Cultural Experience
- 5+ years of relevant experience
- Functional Breadth
- Collaborating across boundaries
- Operations Management and Execution
- Project Management
- Clinical Study Reports
- Data Analysis
- Documentation Management
- Lifesciences
- Operational Excellence
- Regulatory Compliance
Desired Qualifications
- Clinical Study Reports
- Data Analysis
- Documentation Management
- Lifesciences
- Operational Excellence
- Regulatory Compliance
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