Coordinate efforts associated with the preparation of regulatory documents or submissions.

Compile and maintain regulatory documentation databases or systems.

Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.

Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.

Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.

Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.

Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.

Coordinate, prepare, or review regulatory submissions for domestic or international projects.

Recommend adjudication of product complaints.

Identify relevant guidance documents, international standards, or consensus standards.

Prepare or maintain technical files as necessary to obtain and sustain product approval.

Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.

Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.

Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.

Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.

Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.

Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.

Obtain clearances for the use of recycled plastics in product packaging.

Direct the collection and preparation of laboratory samples as requested by regulatory agencies.

Develop or track quality metrics.

Write or update standard operating procedures, work instructions, or policies.

Review clinical protocols to ensure collection of data needed for regulatory submissions.

Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.

Recommend changes to company procedures in response to changes in regulations or standards.

Participate in internal or external audits.

Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.

Develop or conduct employee regulatory training.

Monitor national or international legislation on ozone-depleting substances or global warming.

Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.

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.

Coordinate recall or market withdrawal activities as necessary.