Regulatory Affairs Specialist I (Admin)

Work Schedule

Environmental Conditions

Job Description

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:

Education and Experience: Bachelors 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 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