Regulatory Affairs Managers

What they do:

Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.

On the job, you would:

  • Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
  • Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
  • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
  • Develop regulatory strategies and implementation plans for the preparation and submission of new products.
  • Establish regulatory priorities or budgets and allocate resources and workloads.
  • Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
  • Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
  • Maintain current knowledge of relevant regulations, including proposed and final rules.
  • Manage activities such as audits, regulatory agency inspections, or product recalls.

Knowledge

  • Law and Government
  • Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.
  • English Language
  • Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
  • 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.
  • 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.
  • Biology
  • Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.
  • 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.
  • Education and Training
  • Knowledge of principles and methods for curriculum and training design, teaching and instruction for individuals and groups, and the measurement of training effects.
  • Chemistry
  • Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo. This includes uses of chemicals and their interactions, danger signs, production techniques, and disposal methods.
  • 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.
  • Computers and Electronics
  • Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.

Skills

  • Reading Comprehension
  • Understanding written sentences and paragraphs in work related documents.
  • 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.
  • Critical Thinking
  • Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
  • Judgment and Decision Making
  • Considering the relative costs and benefits of potential actions to choose the most appropriate one.
  • Time Management
  • Managing one's own time and the time of others.
  • Monitoring
  • Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.
  • Coordination
  • Adjusting actions in relation to others' actions.
  • Systems Analysis
  • Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes.

Abilities

  • Written Comprehension
  • The ability to read and understand information and ideas presented in writing.
  • Oral Expression
  • The ability to communicate information and ideas in speaking so others will understand.
  • Written Expression
  • The ability to communicate information and ideas in writing 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.
  • Speech Clarity
  • The ability to speak clearly so others can understand you.
  • Speech Recognition
  • The ability to identify and understand the speech of another person.
  • 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).

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.
  • Communicating with Supervisors, Peers, or Subordinates
  • Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
  • Communicating with Persons Outside Organization
  • Communicating with people outside the organization, representing the organization to customers, the public, government, and other external sources. This information can be exchanged in person, in writing, or by telephone or e-mail.
  • Updating and Using Relevant Knowledge
  • Keeping up-to-date technically and applying new knowledge to your job.
  • Organizing, Planning, and Prioritizing Work
  • Developing specific goals and plans to prioritize, organize, and accomplish your work.
  • Establishing and Maintaining Interpersonal Relationships
  • Developing constructive and cooperative working relationships with others, and maintaining them over time.
  • Making Decisions and Solving Problems
  • Analyzing information and evaluating results to choose the best solution and solve problems.
  • Documenting/Recording Information
  • Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.
  • Interpreting the Meaning of Information for Others
  • Translating or explaining what information means and how it can be used.

Interests

  • 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
  • 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
  • Social
  • Social occupations frequently involve working with, communicating with, and teaching people. These occupations often involve helping or providing service to others.
  • 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.
  • 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.
  • 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.
  • 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.
  • Initiative
  • Job requires a willingness to take on responsibilities and challenges.
  • Leadership
  • Job requires a willingness to lead, take charge, and offer opinions and direction.
  • Stress Tolerance
  • Job requires accepting criticism and dealing calmly and effectively with high stress situations.
  • 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.
  • Cooperation
  • Job requires being pleasant with others on the job and displaying a good-natured, cooperative attitude.
  • Persistence
  • Job requires persistence in the face of obstacles.