Regulatory Affairs Specialists Go Back to List 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.

Technology used in this occupation:
	Data base user interface and query software

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.

Skills
	Reading Comprehension - Understanding written sentences and paragraphs in work related documents.
	Critical Thinking - Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
	Writing - Communicating effectively in writing as appropriate for the needs of the audience.
	Speaking - Talking to others to convey information effectively.
	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.
	Complex Problem Solving - Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
	Judgment and Decision Making - Considering the relative costs and benefits of potential actions to choose the most appropriate one.
	Systems Analysis - Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes.
	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.
	Time Management - Managing one's own time and the time of others.

Knowledge
	English Language - Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
	Law and Government - Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.
	Clerical - Knowledge of administrative and clerical procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and other office procedures and terminology.
	Computers and Electronics - Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.
	Administration and Management - Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.
	Medicine and Dentistry - Knowledge of the information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures.
	Biology - Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.
	Mathematics - Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.
	Customer and Personal Service - Knowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction.
	Production and Processing - Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods.

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Education & Training   Education:   Most of these occupations require a four-year bachelor's degree, but some do not.   Related 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.

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Wage Information
	Region Average Entry Level  Mid-Range  Annual  Hourly  Statewide $90,461.00 $43.50  $27.50  $30.97 - $51.03  Bridgeport/Stamford $93,714.00 $45.06  $27.03  $30.37 - $56.38  Danbury $88,891.00 $42.74  $26.04  $29.88 - $49.91  Hartford $90,522.00 $43.52  $28.50  $31.61 - $50.95  New Haven $87,922.00 $42.27  $26.85  $30.79 - $49.04  New London/Norwich $87,177.00 $41.92  $30.19  $33.81 - $46.10  Waterbury $76,693.00 $36.87  $24.52  $26.70 - $44.56  Torrington $77,213.00 $37.12  $24.30  $23.56 - $46.10

Occupation Outlook ( 2016 - 2026 ) Average Annual Job Openings:   283   Employment in this occupation is expected to grow about as fast as average, and the number of annual openings will offer very good job opportunities.

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	Some of the occupational information on this page is formulated from O*NETTM v17.0 data. O*NETTM is a trademark of the U.S. Department of Labor, Employment and Training Administration.