Regulatory Affairs Specialists
Core Tasks Include:
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- 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.
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
- Compile and maintain regulatory documentation databases or systems.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
- Develop or conduct employee regulatory training.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
- Participate in internal or external audits.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Recommend changes to company procedures in response to changes in regulations or standards.
- Review clinical protocols to ensure collection of data needed for regulatory submissions.
- Write or update standard operating procedures, work instructions, or policies.
- Coordinate recall or market withdrawal activities as necessary.
- Develop or track quality metrics.
- Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
- Identify relevant guidance documents, international standards, or consensus standards.
- Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
- Recommend adjudication of product complaints.
Supplemental Tasks Include:
- Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
- Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
- 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 legal implications of 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.
The data sources for the information displayed here include: O*NET™.