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TASK
Regulatory Affairs Specialists
ID
work_business_financial/regulatory_affairs_specialists
Type
TASK
Children
30
Child Nodes (30)
ATOMIC
Coordinate efforts associated with the preparation of regulatory documents or submissions.
ATOMIC
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
ATOMIC
Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
ATOMIC
Coordinate, prepare, or review regulatory submissions for domestic or international projects.
ATOMIC
Prepare or maintain technical files as necessary to obtain and sustain product approval.
ATOMIC
Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
ATOMIC
Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
ATOMIC
Coordinate recall or market withdrawal activities as necessary.
ATOMIC
Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
ATOMIC
Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
ATOMIC
Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
ATOMIC
Identify relevant guidance documents, international standards, or consensus standards.
ATOMIC
Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
ATOMIC
Review clinical protocols to ensure collection of data needed for regulatory submissions.
ATOMIC
Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
ATOMIC
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
ATOMIC
Recommend changes to company procedures in response to changes in regulations or standards.
ATOMIC
Participate in internal or external audits.
ATOMIC
Compile and maintain regulatory documentation databases or systems.
ATOMIC
Write or update standard operating procedures, work instructions, or policies.
ATOMIC
Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
ATOMIC
Develop or track quality metrics.
ATOMIC
Develop or conduct employee regulatory training.
ATOMIC
Recommend adjudication of product complaints.
ATOMIC
Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
ATOMIC
Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
ATOMIC
Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
ATOMIC
Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.
ATOMIC
Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
ATOMIC