Regulatory Affairs Specialist I (Admin)

Work Schedule

Environmental Conditions

RCR 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 required
  

Qualifications:

Knowledge, Skills and Abilities:

• Good English language (written and oral) communication skills as well as local language where applicable
• Good attention to detail and quality as well as editorial/proofreading skills
• Good interpersonal skills to work effectively in a team environment
• Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
• Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
• Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management
• Good analytical, investigative and problem-solving skills
• Capable of interpreting data