Description
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.
- • 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.
- • Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
- • 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.
- • Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
- • Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
- • 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.
- • Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.
- • 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.
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O*NET occupational data (work activities, skills, knowledge).
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Last reviewed: Jan 2026
