Regulatory Affairs Specialists
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.
What is this job like?
- Write or update standard operating procedures, work instructions, or policies.
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Coordinate recall or market withdrawal activities as necessary.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
- Identify relevant guidance documents, international standards, or consensus standards.
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
- Identify relevant guidance documents, international standards, or consensus standards.
- Review clinical protocols to ensure collection of data needed for regulatory submissions.
- Participate in internal or external audits.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- Recommend adjudication of product complaints.
- Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
- Identify relevant guidance documents, international standards, or consensus standards.
- Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
- Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
- Recommend adjudication of product complaints.
- Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
- 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.
- Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.
- Monitor national or international legislation on ozone-depleting substances or global warming.
- Obtain clearances for the use of recycled plastics in product packaging.
- Recommend changes to company procedures in response to changes in regulations or standards.
- Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.
- Develop or track quality metrics.
- Compile and maintain regulatory documentation databases or systems.
- Recommend adjudication of product complaints.
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
- 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.
- Write or update standard operating procedures, work instructions, or policies.
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
Local Wage Data
Showing wage data for: New Orleans
Entry
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Salary
Hourly Wage
$37,300
$62,980
$102,640
$17.93
$30.28
$49.35