Regulatory Affairs Specialists

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Also known as:
Air Pollution Compliance Inspector, Compliance Investigator, Driver's License Examiner, EEO Officer, Environmental Compliance Inspector, Equal Employment Opportunity Investigator, Equal Employment Opportunity Officer, Equal Employment Opportunity Representative, Immigration Investigator, Inspector of Weights and Measures

SNAPSHOT
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.
Leadership
HIGH
Critical decision making
LOW
Level of responsibilities
LOW
Job challenge and pressure to meet deadlines
HIGH
Dealing and handling conflict
LOW
Communication with others
HIGH
Work closely with team members, clients etc.
HIGH
Comfort of the work setting
HIGH
Exposure to extreme environmental conditions
LOW
Exposure to job hazards
LOW
Physical demands
LOW
Daily tasks

Coordinate recall or market withdrawal activities as necessary.

Review clinical protocols to ensure collection of data needed for regulatory submissions.

Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.

Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.

Recommend adjudication of product complaints.

Develop or conduct employee regulatory training.

Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.

Recommend changes to company procedures in response to changes in regulations or standards.

Participate in internal or external audits.

Compile and maintain regulatory documentation databases or systems.

Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.

MAIN 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.
Interacting With Computers Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.
Making Decisions and Solving Problems Analyzing information and evaluating results to choose the best solution and solve problems.
Interpreting the Meaning of Information for Others Translating or explaining what information means and how it can be used.
Updating and Using Relevant Knowledge Keeping up-to-date technically and applying new knowledge to your job.
AREAS OF 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.
Biology Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.
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.
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.
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.
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.
TOP SKILLS
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.
Writing Communicating effectively in writing as appropriate for the needs of the audience.
Speaking Talking to others to convey information effectively.
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.
Reading Comprehension Understanding written sentences and paragraphs in work related documents.
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.