Regulatory Affairs Managers

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Also known as:  Clerk of Court, Director of Entertainment, Environmental Control Administrator, Highway Patrol Commander, Safety Coordinator, Social Science Manager, Utilities Manager
SNAPSHOT Expand
Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
Leadership
HIGH
Critical decision making
HIGH
Level of responsibilities
LOW
Job challenge and pressure to meet deadlines
HIGH
Dealing and handling conflict
LOW
Competition for this position
MED
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
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DAILY TASKS Expand
Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
Establish procedures or systems for publishing document submissions either in hardcopy or electronic formats.
Manage activities such as audits, regulatory agency inspections, or product recalls.
Contribute to the development or implementation of business unit strategic and operating plans.
Develop and maintain standard operating procedures or local working practices.
Establish regulatory priorities or budgets and allocate resources and workloads.
Provide responses to regulatory agencies regarding product information or issues.
Participate in the development or implementation of clinical trial protocols.
Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
Develop regulatory strategies and implementation plans for the preparation and submission of new products.
MAIN ACTIVITIES Expand
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.
AREAS OF KNOWLEDGE Expand
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.
KEY ABILITIES Expand
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.
Speech Clarity The ability to speak clearly so others can understand you.
Inductive Reasoning The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events).
TOP SKILLS Expand
Reading Comprehension Understanding written sentences and paragraphs in work related documents.
Speaking Talking to others to convey information effectively.
Writing Communicating effectively in writing as appropriate for the needs of the audience.
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.
Coordination Adjusting actions in relation to others' actions.
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