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Career Description

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

What Job Titles Regulatory Affairs Managers Might Have

• Clinical Trials Systems Administrator
• Global Regulatory Affairs Manager
• Regulatory Affairs Director
• Regulatory Affairs Manager

What Regulatory Affairs Managers Do

• Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
• Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
• Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
• Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
• Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
• Manage activities such as audits, regulatory agency inspections, or product recalls.
• Develop regulatory strategies and implementation plans for the preparation and submission of new products.
• Provide responses to regulatory agencies regarding product information or issues.
• Maintain current knowledge of relevant regulations, including proposed and final rules.
• Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
• Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
• Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
• Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
• Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.
• Participate in the development or implementation of clinical trial protocols.
• Develop and maintain standard operating procedures or local working practices.
• Establish regulatory priorities or budgets and allocate resources and workloads.
• Train staff in regulatory policies or procedures.
• Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
• Establish procedures or systems for publishing document submissions either in hardcopy or electronic formats.
• Contribute to the development or implementation of business unit strategic and operating plans.
• Coordinate internal discoveries and depositions with legal department staff.

What Regulatory Affairs Managers Should Be Good At

• Written Comprehension - The ability to read and understand information and ideas presented in writing.
• Oral Comprehension - The ability to listen to and understand information and ideas presented through spoken words and sentences.
• 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.
• 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).
• 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).
• Speech Recognition - The ability to identify and understand the speech of another person.
• Near Vision - The ability to see details at close range (within a few feet of the observer).
• Fluency of Ideas - The ability to come up with a number of ideas about a topic (the number of ideas is important, not their quality, correctness, or creativity).

What Regulatory Affairs Managers Should Be Interested In

• 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.
• 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.

What Regulatory Affairs Managers Need to Learn

• 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.
• 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.