Regulatory Affairs Specialists

What they do:

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.

On the job, you would:

  • 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.

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.

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.

Abilities

  • Written Comprehension
  • The ability to read and understand information and ideas presented in writing.
  • Written Expression
  • The ability to communicate information and ideas in writing so others will understand.
  • Oral Expression
  • The ability to communicate information and ideas in speaking so others will understand.
  • Oral Comprehension
  • The ability to listen to and understand information and ideas presented through spoken words and sentences.
  • Problem Sensitivity
  • The ability to tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing there is a problem.
  • Deductive Reasoning
  • The ability to apply general rules to specific problems to produce answers that make sense.
  • Inductive Reasoning
  • The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events).
  • Information Ordering
  • The ability to arrange things or actions in a certain order or pattern according to a specific rule or set of rules (e.g., patterns of numbers, letters, words, pictures, mathematical operations).
  • Near Vision
  • The ability to see details at close range (within a few feet of the observer).
  • Speech Clarity
  • The ability to speak clearly so others can understand you.

Work Activities

  • Evaluating Information to Determine Compliance with Standards
  • Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards.
  • Getting Information
  • Observing, receiving, and otherwise obtaining information from all relevant sources.
  • Updating and Using Relevant Knowledge
  • Keeping up-to-date technically and applying new knowledge to your job.
  • Interacting With Computers
  • Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.
  • Communicating with Supervisors, Peers, or Subordinates
  • Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
  • Organizing, Planning, and Prioritizing Work
  • Developing specific goals and plans to prioritize, organize, and accomplish your work.
  • Processing Information
  • Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.
  • Establishing and Maintaining Interpersonal Relationships
  • Developing constructive and cooperative working relationships with others, and maintaining them over time.
  • Interpreting the Meaning of Information for Others
  • Translating or explaining what information means and how it can be used.
  • Making Decisions and Solving Problems
  • Analyzing information and evaluating results to choose the best solution and solve problems.

Interests

  • Conventional
  • Conventional occupations frequently involve following set procedures and routines. These occupations can include working with data and details more than with ideas. Usually there is a clear line of authority to follow.
  • First Interest High-Point
  • Primary-Rank Descriptiveness
  • Enterprising
  • Enterprising occupations frequently involve starting up and carrying out projects. These occupations can involve leading people and making many decisions. Sometimes they require risk taking and often deal with business.
  • Second Interest High-Point
  • Secondary-Cutoff/Rank Descriptiveness
  • Investigative
  • Investigative occupations frequently involve working with ideas, and require an extensive amount of thinking. These occupations can involve searching for facts and figuring out problems mentally.
  • Realistic
  • Realistic occupations frequently involve work activities that include practical, hands-on problems and solutions. They often deal with plants, animals, and real-world materials like wood, tools, and machinery. Many of the occupations require working outside, and do not involve a lot of paperwork or working closely with others.
  • Social
  • Social occupations frequently involve working with, communicating with, and teaching people. These occupations often involve helping or providing service to others.
  • Artistic
  • Artistic occupations frequently involve working with forms, designs and patterns. They often require self-expression and the work can be done without following a clear set of rules.
  • Third Interest High-Point
  • Tertiary-Cutoff/Rank Descriptiveness

Work Styles

  • Integrity
  • Job requires being honest and ethical.
  • Attention to Detail
  • Job requires being careful about detail and thorough in completing work tasks.
  • Dependability
  • Job requires being reliable, responsible, and dependable, and fulfilling obligations.
  • Adaptability/Flexibility
  • Job requires being open to change (positive or negative) and to considerable variety in the workplace.
  • Analytical Thinking
  • Job requires analyzing information and using logic to address work-related issues and problems.
  • Stress Tolerance
  • Job requires accepting criticism and dealing calmly and effectively with high stress situations.
  • Persistence
  • Job requires persistence in the face of obstacles.
  • Initiative
  • Job requires a willingness to take on responsibilities and challenges.
  • Cooperation
  • Job requires being pleasant with others on the job and displaying a good-natured, cooperative attitude.
  • Achievement/Effort
  • Job requires establishing and maintaining personally challenging achievement goals and exerting effort toward mastering tasks.