Regulatory Affairs Specialist I (Admin)

ConfidentialBengaluru / Bangalore, India

23 hours ago

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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

Skills Required

Microsoft Word

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Regulatory Specialist • Bengaluru / Bangalore, India