Regulatory Affairs Specialists — Tasks

Task statements

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