Regulatory Executive
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Accentuate Staffing is working with one of our long-time clients in the Raleigh area on their search for a Regulatory Executive. This is a strategic role requiring a solid regulatory knowledge base!
Responsibilities:
- Responsible for analyzing a client’s data to identify potential issues and gaps on projects – so that they can be integrated into the key messages, documents, and presentations.
- Responsible for evaluating the scientific or regulatory environment to predict things that influence data interpretation (e.g., profiling, standard of care, evolution in scientific interpretation).
- Provide clients with strategic recommendations that help enhance credibility of data interpretation and communications and alignment with statutory requirements in key markets.
Requirements:
- A graduate degree (master’s degree or above) in a scientific, regulatory, or related field, or a bachelor’s degree with at least ten (10) years’ related work experience;
- At least five (5) years’ experience in scientific or regulatory environment performing services in the analysis and development of scientific or regulatory data;\
- Thorough understand of US/EU pharmaceutical regulatory approval processes;
- Familiarity with Microsoft Office programs, including MS Word, Excel, and PowerPoint;
- Familiarity with Salesforce, Dropbox, Citrix preferred
- Skilled in organizational development, personnel management, budget and resource development, and strategic planning
