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Senior Regulatory Intelligence Officer
hace 3 semanas
Principal Accountabilities
- Real time monitoring and analysis of changes in the regulatory landscape for an assigned set of countries
- Prepares and/or reviews regulatory documentation in area of expertise, as appropriate
- Management of the content provided by our network of consultants and participate in the identification and evaluation of new Local Experts when required
- Acts as an SME/ expert in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable
- Depending on experience, give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development
- Liaising with internal and external stakeholders to provide expert support
- May act as reviewer for regulatory standard operating procedures, as assigned and appropriate
- May prepare and deliver regulatory training to IQVIA small groups or individuals
- Performs other tasks or assignments, as delegated by Operations management.
- As required, actively interacts with customers to discuss regulatory issues and discuss customer comments.
Essential Experience
- Qualifications in life sciences or related discipline
- Subject matter expert (SME) in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labelling/ Publishing as applicable
- Full understanding of scientific principles and regulatory requirements relevant to the Regulatory Development process for medicinal products
Technical Skills
- Experience & knowledge of various databases (public/proprietary)
- Proficient in MS Office - Excel, Word, PowerPoint
Personal Skills
- Flexibility (should be ready to take additional responsibility as and when required)
- Strong interpersonal skills and ability to interact at all levels within IQVIA and with customers
- Ability to follow standard operating procedures consistently; provides independent thought to assist in process improvements.
- Demonstrates self-motivation and enthusiasm; desire to learn new concepts and skills
- Excellent English communication (verbal/written) skills
- Strong attention to detail
- Ability to solve problems quickly and logically
- Team player and ability to collaborate at all levels but also able to work under own initiative
- Adept time and project management
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