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.

Median Annual Wage: $64,950

Education: Bachelor's degree (78%); Post-baccalaureate certificate (9%); Master's degree (6%)

Projected Growth: Slower than average (3% to 7%)

Related Job Titles: Drug Regulatory Affairs Specialist; Quality Assurance/Regulatory Affairs Specialist (QA/RA Specialist); Regulatory Affairs Analyst; Regulatory Affairs Associate; Regulatory Affairs Consultant; Regulatory Affairs Specialist; Regulatory Affairs Strategy Specialist; Regulatory Associate; Regulatory Services Consultant; Regulatory Submissions Associate

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Source: O*NET OnLine information for Regulatory Affairs Specialists.

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  • Provide technical review of data or reports that will 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.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Prepare or maintain technical files as necessary to obtain and sustain product approval.
  • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
  • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
  • 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.
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
  • Analyze product complaints and make recommendations regarding their reportability.
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
  • Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
  • Review clinical protocols to ensure collection of data needed for regulatory submissions.
  • Compile and maintain regulatory documentation databases or systems.
  • Recommend changes to company procedures in response to changes in regulations or standards.
  • Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
  • Write or update standard operating procedures, work instructions, or policies.
  • Participate in internal or external audits.
  • Develop or conduct employee regulatory training.
  • Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.

Source: O*NET OnLine information for Regulatory Affairs Specialists.

  • Writing - Communicating effectively in writing as appropriate for the needs of the audience.
  • Critical Thinking - Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
  • Speaking - Talking to others to convey information effectively.
  • Judgment and Decision Making - Considering the relative costs and benefits of potential actions to choose the most appropriate one.
  • Active Listening - Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
  • Systems Analysis - Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes.
  • Complex Problem Solving - Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
  • Active Learning - Understanding the implications of new information for both current and future problem-solving and decision-making.
  • Systems Evaluation - Identifying measures or indicators of system performance and the actions needed to improve or correct performance, relative to the goals of the system.

Source: O*NET OnLine information for Regulatory Affairs Specialists.

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