Regulatory Affairs Specialist

Rx Research Services

National (OA)

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Work Process Schedule

Work Process Content

On the Job Training

Anonymous

3.6K

OJT hours

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

190

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

180

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

180

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

180

Ensure current regulations are communicated through corporate policies and procedures.

180

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

180

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

180

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

Coordinate efforts associated with the preparation of regulatory documents or submissions, and develop timelines for submissions.

180

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

180

Analyze product complaints and make recommendations regarding their reportability.

180

Participate in internal or external audits.

170

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

160

Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.

160

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

Compile and maintain regulatory documentation databases or systems.

160

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

160

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

150

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

140

Escort government inspectors during inspections and provide post-inspection follow-up information as requested.

140

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

130

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

170

Coordinate recall or market withdrawal activities as necessary.

170

Ensure collection and preparation of laboratory samples is conducted in accordance with GLP compliance.

130

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Regulatory Affairs Specialist

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