Regulatory Intelligence Specialist

October 11

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Parexel

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Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+

💰 Venture Round on 1990-01

Description

• Lead and coordinate all Regulatory Intelligence activities, including research on regulatory updates, communication to stakeholders, and tracking the impact and implementation actions. • Act as the point person for regulatory intelligence related consultancy. • Assist the Parexel Quality group in the preparation for and follow-up of internal/external audits and inspections, as needed and relevant to Regulatory Intelligence Activities. • Maintain the Regulatory Intelligence SharePoint and filing areas. • Provide technical knowledge where appropriate. • Collaborate with Parexel Quality to develop and update quality/process documents, tools, and templates in line with regulatory intelligence activities. • Generate metrics on Regulatory Intelligence Activities. • Contribute to the metrics provided to Senior Management. • Complete assigned goals for key QMS elements, with a special focus on Knowledge Management/Regulatory intelligence activities and oversight. • Undertake other duties as assigned.

Requirements

• Educated to degree level (technology, biological science, pharmacy, or other health-related discipline preferred) or equivalent qualification or clinical research experience. • Experience in Quality Assurance, Quality Management, Regulatory Affairs, Clinical Research, Monitoring, Data Management, Pharmacy, Laboratory, or other relevant areas. • Good understanding of regulatory affairs landscape • Experience working with clinical trials • Project management capabilities applicable to Regulatory Intelligence activities and oversight. • Excellent interpersonal, verbal, and written communication skills, including the ability to present at meetings and training sessions. • Ability to rapidly learn, understand, and apply applicable corporate procedures. • Excellent time management skills, with the ability to prioritize workload and manage multiple tasks/projects with enthusiasm. • Ability to lead projects and teams. • Strong ability to analyze and interpret data. • Attention to detail and advanced organizational skills. • IT literate, with a strong ability to work with Microsoft-based applications and relevant Regulatory Intelligence applications such as Cortellis or Tarius • Proficiency in written and oral English.