What do Regulatory Affairs Specialists do?
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Provide technical review of data or reports that will 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.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- 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.
- Analyze product complaints and make recommendations regarding their reportability.
- Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
- Review clinical protocols to ensure collection of data needed for regulatory submissions.
- 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.
- Write or update standard operating procedures, work instructions, or policies.
- Participate in internal or external audits.
- Develop or conduct employee regulatory training.
- Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
- Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
- Coordinate recall or market withdrawal activities as necessary.
- Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
- Develop or track quality metrics.
- Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
- Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
- Determine the effects of legal requirements related to the production, supply, or use of ozone-depleting substances or equipment containing such substances.
- Monitor national or international legislation on ozone-depleting substances or global warming.
- Obtain clearances for the use of recycled plastics in product packaging.
- Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.
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