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Regulatory Affairs Specialist

Published
Hybrid Apprenticeship
Sponsoring Company:
Rx Research Services
O*Net Code
13-1041.07
Rapids Code
2062HY
Req. Hours
2760
State
DC
Created
Jul 29, 2021
Updated
Jul 29, 2021

Time-Based Skills

23 skill sets | 23 total skills
Coordinate, prepare, or review regulatory submissions for domestic or international projects. - 130 req. hrs
Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation. - 125 req. hrs
Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies. - 125 req. hrs
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents. - 125 req. hrs
Ensure current regulations are communicated through corporate policies and procedures. - 125 req. hrs
Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes. - 125 req. hrs
Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues. - 125 req. hrs
Prepare or maintain technical files as necessary to obtain and sustain product approval. - 125 req. hrs
Coordinate efforts associated with the preparation of regulatory documents or submissions, and develop timelines for submissions. - 120 req. hrs
Prepare or direct the preparation of additional information or responses as requested by regulatory agencies. - 120 req. hrs
Analyze product complaints and make recommendations regarding their report ability. - 120 req. hrs
Participate in internal or external audits. - 120 req. hrs
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. - 120 req. hrs
Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance. - 115 req. hrs
Review clinical protocols to ensure collection of data needed for regulatory submissions. - 115 req. hrs
Compile and maintain regulatory documentation databases or systems. - 115 req. hrs
Recommend changes to company procedures in response to changes in regulations or standards. - 115 req. hrs
Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards. - 115 req. hrs
Write or update standard operating procedures, work instructions, or policies. - 115 req. hrs
Escort government inspectors during inspections and provide post-inspection follow-up information as requested. - 115 req. hrs
Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires. - 110 req. hrs
Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines. - 120 req. hrs
Coordinate recall or market withdrawal activities as necessary. - 120 req. hrs

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