Regulatory affairs specialist 1(thermofisher)

Roles and Responsibilities

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: 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 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