Regulatory Affairs Specialist I (Admin)

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeRCR Specialist (Admin), Regulatory Compliance Review, Regulatory Affairs Perform global regulatory compliance review of essential documents supporting the customization of study-specific Essential Document Checklists Respond to project teams on queries on Essential Document Checklist requirements Where required/applicable, facilitate discussion of requirement of deviation to the RCR process with the project teams Ensure effective management and coordination of the Essential Document Checklist Process Maintain knowledge and understanding of PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided Responsible for reviewing, finalizing and posting of the Essential Document Checklists Other duties as requiredQualifications: Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 to 3 years)Knowledge, Skills and Abilities:Good English language (written and oral) communication skills as well as local language where applicableGood attention to detail and quality as well as editorial/proofreading skillsGood interpersonal skills to work effectively in a team environmentGood computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologiesBasic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projectsBasic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle managementGood analytical, investigative and problem-solving skillsCapable of interpreting data