According to people in this career, the main tasks are...
| Task | Importance |
|---|---|
| Coordinate efforts associated with the preparation of regulatory documents or submissions. | 91% |
| Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. | 91% |
| Prepare or direct the preparation of additional information or responses as requested by regulatory agencies. | 91% |
| Coordinate, prepare, or review regulatory submissions for domestic or international projects. | 90% |
| Prepare or maintain technical files as necessary to obtain and sustain product approval. | 89% |
| Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures. | 88% |
| Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes. | 88% |
| Coordinate recall or market withdrawal activities as necessary. | 87% |
| Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues. | 86% |
| Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines. | 86% |
| Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies. | 86% |
| Identify relevant guidance documents, international standards, or consensus standards. | 85% |
| Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation. | 84% |
| Review clinical protocols to ensure collection of data needed for regulatory submissions. | 80% |
| Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors. | 80% |
| Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents. | 80% |
| Recommend changes to company procedures in response to changes in regulations or standards. | 79% |
| Participate in internal or external audits. | 76% |
| Compile and maintain regulatory documentation databases or systems. | 75% |
| Write or update standard operating procedures, work instructions, or policies. | 71% |
| Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards. | 69% |
| Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste. | 66% |
| Develop or track quality metrics. | 65% |
| Develop or conduct employee regulatory training. | 64% |
| Recommend adjudication of product complaints. | 64% |
| Direct the collection and preparation of laboratory samples as requested by regulatory agencies. | 63% |
| Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires. | 58% |
| Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops. | 48% |
| Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste. | 45% |
| Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances. | 43% |
| Obtain clearances for the use of recycled plastics in product packaging. | 30% |
| Monitor national or international legislation on ozone-depleting substances or global warming. | 30% |
