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Career: Regulatory Affairs Managers

Job Description

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


Job Tasks

Importance %age

Task Description
100
Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, and compliance with regulatory standards.
100
Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
100
Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
100
Provide responses to regulatory agencies regarding product information or issues.
100
Maintain current knowledge of relevant regulations including proposed and final rules.
100
Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.
100
Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
97
Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
97
Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
97
Develop regulatory strategies and implementation plans for the preparation and submission of new products.
97
Develop and maintain standard operating procedures or local working practices.
97
Establish regulatory priorities or budgets and allocate resources and workloads.
94
Manage activities such as audits, regulatory agency inspections, and product recalls.
94
Contribute to the development or implementation of business unit strategic and operating plans.
91
Review materials such as marketing literature and user manuals to ensure that regulatory agency requirements are met.
91
Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
91
Train staff in regulatory policies or procedures.
91
Establish procedures or systems for publishing document submissions either in hardcopy or electronic formats.
88
Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
88
Participate in the development or implementation of clinical trial protocols.
85
Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
76
Evaluate new software publishing systems and confer with regulatory agencies concerning news and updates related to electronic publishing of submissions.
67
Coordinate internal discoveries and depositions with legal department staff.

Work Activities

Importance %age

Activity Description
85
Organizing, Planning, and Prioritizing Work
  • Developing specific goals and plans to prioritize, organize, and accomplish your work.
    		•
    81
    		Getting Information
  • Observing, receiving, and otherwise obtaining information from all relevant sources.
    		•
    80
    		Communicating with Supervisors, Peers, or Subordinates
  • Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
    		•
    80
    		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.
    		•
    77
    		Updating and Using Relevant Knowledge
  • Keeping up-to-date technically and applying new knowledge to your job.
    		•
    76
    		Establishing and Maintaining Interpersonal Relationships
  • Developing constructive and cooperative working relationships with others, and maintaining them over time.
    		•
    74
    		Resolving Conflicts and Negotiating with Others
  • Handling complaints, settling disputes, and resolving grievances and conflicts, or otherwise negotiating with others.
    		•
    74
    		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.
    		•
    73
    		Processing Information
  • Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.
    		•
    71
    		Coaching and Developing Others
  • Identifying the developmental needs of others and coaching, mentoring, or otherwise helping others to improve their knowledge or skills.
    		•
    71
    		Provide Consultation and Advice to Others
  • Providing guidance and expert advice to management or other groups on technical, systems-, or process-related topics.
    		•
    69
    		Identifying Objects, Actions, and Events
  • Identifying information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events.
    		•
    69
    		Interpreting the Meaning of Information for Others
  • Translating or explaining what information means and how it can be used.
    		•
    68
    		Making Decisions and Solving Problems
  • Analyzing information and evaluating results to choose the best solution and solve problems.
    		•
    68
    		Coordinating the Work and Activities of Others
  • Getting members of a group to work together to accomplish tasks.
    		•
    67
    		Scheduling Work and Activities
  • Scheduling events, programs, and activities, as well as the work of others.
    		•
    63
    		Documenting/Recording Information
  • Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.
    		•
    63
    		Analyzing Data or Information
  • Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.
    		•
    63
    		Guiding, Directing, and Motivating Subordinates
  • Providing guidance and direction to subordinates, including setting performance standards and monitoring performance.
    		•
    62
    		Developing Objectives and Strategies
  • Establishing long-range objectives and specifying the strategies and actions to achieve them.
    		•
    61
    		Staffing Organizational Units
  • Recruiting, interviewing, selecting, hiring, and promoting employees in an organization.
    		•
    59
    		Developing and Building Teams
  • Encouraging and building mutual trust, respect, and cooperation among team members.
    		•
    59
    		Performing Administrative Activities
  • Performing day-to-day administrative tasks such as maintaining information files and processing paperwork.
    		•
    58
    		Training and Teaching Others
  • Identifying the educational needs of others, developing formal educational or training programs or classes, and teaching or instructing others.
    		•
    57
    		Thinking Creatively
  • Developing, designing, or creating new applications, ideas, relationships, systems, or products, including artistic contributions.
    		•
    54
    		Monitoring and Controlling Resources
  • Monitoring and controlling resources and overseeing the spending of money.
    		•
    54
    		Monitor Processes, Materials, or Surroundings
  • Monitoring and reviewing information from materials, events, or the environment, to detect or assess problems.
    		•
    52
    		Selling or Influencing Others
  • Convincing others to buy merchandise/goods or to otherwise change their minds or actions.
    		•
    50
    		Judging the Qualities of Things, Services, or People
  • Assessing the value, importance, or quality of things or people.
    		•
    46
    		Interacting With Computers
  • Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.
    		•
    45
    		Estimating the Quantifiable Characteristics of Products, Events, or Information
  • Estimating sizes, distances, and quantities; or determining time, costs, resources, or materials needed to perform a work activity.
    		•
    34
    		Inspecting Equipment, Structures, or Material
  • Inspecting equipment, structures, or materials to identify the cause of errors or other problems or defects.
    		•
    31
    		Assisting and Caring for Others
  • Providing personal assistance, medical attention, emotional support, or other personal care to others such as coworkers, customers, or patients.
    		•
    25
    		Handling and Moving Objects
  • Using hands and arms in handling, installing, positioning, and moving materials, and manipulating things.
    		•
    25
    		Performing for or Working Directly with the Public
  • Performing for people or dealing directly with the public. This includes serving customers in restaurants and stores, and receiving clients or guests.
    		•
    16
    		Controlling Machines and Processes
  • Using either control mechanisms or direct physical activity to operate machines or processes (not including computers or vehicles).
    		•
    14
    		Drafting, Laying Out, and Specifying Technical Devices, Parts, and Equipment
  • Providing documentation, detailed instructions, drawings, or specifications to tell others about how devices, parts, equipment, or structures are to be fabricated, constructed, assembled, modified, maintained, or used.
    		•
    10
    		Performing General Physical Activities
  • Performing physical activities that require considerable use of your arms and legs and moving your whole body, such as climbing, lifting, balancing, walking, stooping, and handling of materials.
    		•
    9
    		Operating Vehicles, Mechanized Devices, or Equipment
  • Running, maneuvering, navigating, or driving vehicles or mechanized equipment, such as forklifts, passenger vehicles, aircraft, or water craft.
    		•
    8
    		Repairing and Maintaining Electronic Equipment
  • Servicing, repairing, calibrating, regulating, fine-tuning, or testing machines, devices, and equipment that operate primarily on the basis of electrical or electronic (not mechanical) principles.
    		•
    3
    		Repairing and Maintaining Mechanical Equipment
  • Servicing, repairing, adjusting, and testing machines, devices, moving parts, and equipment that operate primarily on the basis of mechanical (not electronic) principles.
    		•
    
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