Regulatory Affairs Specialists
SOC: 13-1041.07

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.


National Salary Information:

Hourly Statistics:

Annual Statistics:

Source: Bureau of Labor Statistics 2015 wage data.


Employment Projections:

Employment (2014):
260,300 employed

Projected (2024):
269,000 employed

Projected growth (2014-2024)


Source: Bureau of Labor Statistics 2015 2014-2024 employment projections external site. "Projected growth" represents the estimated change in total employment over the projections period (2014-2024). "Projected job openings" represent openings due to growth and replacement.


Alternate Titles:

  • Clinical Quality Assurance Associate
  • Clinical Quality Assurance Specialist
  • Drug Regulatory Affairs Specialist
  • Product Safety Specialist
  • Quality Assurance Documentation Coordinator
  • Quality Assurance Documentation Specialist
  • Quality Assurance Specialist
  • Quality Assurance/Regulatory Affairs Specialist (QA/RA Specialist)
  • Regulatory Affairs Analyst
  • Regulatory Affairs Associate
  • Regulatory Affairs Consultant
  • Regulatory Affairs Coordinator
  • Regulatory Affairs Specialist
  • Regulatory Affairs Strategy Specialist
  • Regulatory Analyst
  • Regulatory Associate
  • Regulatory Compliance Specialist
  • Regulatory Services Consultant
  • Regulatory Specialist
  • Regulatory Submissions Associate
  • Research Compliance Specialist
  • Research Quality Assurance Analyst
  • Research Quality Assurance Specialist


  • Job Zone Four: Considerable Preparation Needed

    Experience:

    A considerable amount of work-related skill, knowledge, or experience is needed for these occupations. For example, an accountant must complete four years of college and work for several years in accounting to be considered qualified.

    Education:

    Most of these occupations require a four-year bachelor's degree, but some do not.

    Job Training:

    Employees in these occupations usually need several years of work-related experience, on-the-job training, and/or vocational training.


    Required Skills:

  • Reading Comprehension
  • Active Listening
  • Writing
  • Speaking
  • Mathematics
  • Science
  • Critical Thinking
  • Active Learning
  • Learning Strategies
  • Monitoring
  • Social Perceptiveness
  • Coordination
  • Persuasion
  • Negotiation
  • Instructing
  • Service Orientation
  • Complex Problem Solving
  • Operations Analysis
  • Technology Design
  • Programming
  • Operation Monitoring
  • Quality Control Analysis
  • Judgment and Decision Making
  • Systems Analysis
  • Systems Evaluation
  • Time Management
  • Management of Financial Resources
  • Management of Material Resources
  • Management of Personnel Resources

  • Knowledge Used:

  • Administration and Management
  • Clerical
  • Economics and Accounting
  • Sales and Marketing
  • Customer and Personal Service
  • Personnel and Human Resources
  • Production and Processing
  • Computers and Electronics
  • Engineering and Technology
  • Design
  • Mechanical
  • Mathematics
  • Physics
  • Chemistry
  • Biology
  • Psychology
  • Sociology and Anthropology
  • Geography
  • Medicine and Dentistry
  • Education and Training
  • English Language
  • Foreign Language
  • History and Archeology
  • Philosophy and Theology
  • Public Safety and Security
  • Law and Government
  • Telecommunications
  • Communications and Media
  • Transportation


  • Tasks:

  • 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.
  • Analyze product complaints and make recommendations regarding their reportability.
  • 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 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.
  • 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.
  • Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
  • 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 effects of legal requirements related to the production, supply, or use of ozone-depleting substances or equipment containing such substances.
  • Monitor national or international legislation on ozone-depleting substances or global warming.
  • Obtain clearances for the use of recycled plastics in product packaging.
  • Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.

  • Tools & Technology:

  • Computer data input scanners
  • Desktop computers
  • Laptop computers
  • Laser facsimile machines
  • Multi-line telephone systems
  • Personal computers
  • Photocopying equipment
  • Adobe Systems Adobe Acrobat software
  • Analyse-it
  • Atrion Intelligent Authoring
  • DataVision software
  • FileMaker Pro software
  • Integrated development environment IDE software
  • Microsoft Access
  • Microsoft Excel
  • Microsoft Office software
  • Microsoft Outlook
  • Microsoft PowerPoint
  • Microsoft Project
  • Microsoft SharePoint software
  • Microsoft Word
  • Oracle software
  • SAP software
  • Statistical software
  • Structured query language SQL
  • Web browser software


  • business and financial operations


    industry stats

    SOC: 13-0000

    Total Employed: 7,032,560

    Average Annual Salary: $73,800