Document Control Specialist for Global Products
5 days ago
This is a challenging role where you will be responsible for ensuring our documentation systems are controlled and compliant with regulatory requirements. Your key responsibilities will include maintaining technical and non-technical documentation change systems, classifying and maintaining records, and enforcing documentation formatting standards.
Key Responsibilities:- Manage global regulatory submission projects of medium to small scale.
- Provide strategic input on submission strategy, intelligence, and knowledge required to develop, register, and maintain global products.
- Contribute to the implementation of global systems, tools, and processes to support global development projects and/or marketed products.
- Establish frequent internal and external contacts.
- Represent the organization on specific projects.
- Work on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
- Report technical complaints/adverse events/special case scenarios related to products within 24 hours of receipt.
- Cross-cultural experience.
- Functional breadth.
- Collaboration across boundaries.
- Operations management and execution.
- Project management.
- Clinical study reports.
- Data analysis.
- Documentation management.
- Lifesciences.
- Operational excellence.
- Regulatory compliance.
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Hyderabad, Telangana, India Latinem Private Limited Full timeAbout Us: Latinem India – Global Capability Centre Latinem is a high-performance Global Capability Centre (GCC) delivering world-class strategic, digital, and operational support to Sobha's markets across the Middle East, the United States, and Australia, the leading developer in the Middle East. Driven by excellence and innovation, Latinem is more than...
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Hyderabad, Telangana, India Latinem Private Limited Full timeAbout Us:Latinem India – Global Capability Centre Latinem is a high-performance Global Capability Centre (GCC) delivering world-class strategic, digital, and operational support to Sobha's markets across the Middle East, the United States, and Australia, the leading developer in the Middle East.Driven by excellence and innovation, Latinem is more than just...
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Hyderabad, Telangana, India BeBeeRegulatory Full timeJob Summary This role involves ensuring a controlled documentation system and record retention in accordance with regulatory requirements. The successful candidate will be responsible for maintaining technical and non-technical documentation change systems, classifying and maintaining records, and enforcing documentation formatting standards. Key...
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