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Career: Regulatory Affairs Specialists

Job Description

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.


Job Tasks

Importance %age

Task Description
100
Coordinate, prepare, or review regulatory submissions for domestic or international projects.
100
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
100
Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
100
Coordinate efforts associated with the preparation of regulatory documents or submissions.
100
Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
100
Recommend changes to company procedures in response to changes in regulations or standards.
97
Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
97
Prepare or maintain technical files as necessary to obtain and sustain product approval.
97
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
97
Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
97
Write or update standard operating procedures, work instructions, or policies.
94
Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
94
Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes and labeling changes.
94
Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, and clinical study compliance issues.
94
Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
94
Compile and maintain regulatory documentation databases and systems.
94
Participate in internal or external audits.
88
Develop or conduct employee regulatory training.
85
Review clinical protocols to ensure collection of data needed for regulatory submissions.
82
Prepare responses to customer requests for information such as product data, written regulatory affairs statements, surveys, and questionnaires.
73
Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
70
Analyze product complaints and make recommendations regarding their reportability.
66
Develop and track quality metrics.
64
Coordinate recall or market withdrawal activities as necessary.
52
Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
52
Direct the collection and preparation of laboratory samples as requested by regulatory agencies.

Work Activities

Importance %age

Activity Description
81
Organizing, Planning, and Prioritizing Work
  • Developing specific goals and plans to prioritize, organize, and accomplish your work.
    		•
    76
    		Updating and Using Relevant Knowledge
  • Keeping up-to-date technically and applying new knowledge to your job.
    		•
    74
    		Getting Information
  • Observing, receiving, and otherwise obtaining information from all relevant sources.
    		•
    73
    		Establishing and Maintaining Interpersonal Relationships
  • Developing constructive and cooperative working relationships with others, and maintaining them over time.
    		•
    73
    		Communicating with Supervisors, Peers, or Subordinates
  • Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
    		•
    73
    		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.
    		•
    71
    		Processing Information
  • Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.
    		•
    68
    		Identifying Objects, Actions, and Events
  • Identifying information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events.
    		•
    67
    		Interpreting the Meaning of Information for Others
  • Translating or explaining what information means and how it can be used.
    		•
    67
    		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.
    		•
    65
    		Making Decisions and Solving Problems
  • Analyzing information and evaluating results to choose the best solution and solve problems.
    		•
    64
    		Analyzing Data or Information
  • Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.
    		•
    63
    		Documenting/Recording Information
  • Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.
    		•
    63
    		Coordinating the Work and Activities of Others
  • Getting members of a group to work together to accomplish tasks.
    		•
    62
    		Scheduling Work and Activities
  • Scheduling events, programs, and activities, as well as the work of others.
    		•
    62
    		Resolving Conflicts and Negotiating with Others
  • Handling complaints, settling disputes, and resolving grievances and conflicts, or otherwise negotiating with others.
    		•
    60
    		Provide Consultation and Advice to Others
  • Providing guidance and expert advice to management or other groups on technical, systems-, or process-related topics.
    		•
    58
    		Performing Administrative Activities
  • Performing day-to-day administrative tasks such as maintaining information files and processing paperwork.
    		•
    58
    		Developing Objectives and Strategies
  • Establishing long-range objectives and specifying the strategies and actions to achieve them.
    		•
    55
    		Thinking Creatively
  • Developing, designing, or creating new applications, ideas, relationships, systems, or products, including artistic contributions.
    		•
    54
    		Developing and Building Teams
  • Encouraging and building mutual trust, respect, and cooperation among team members.
    		•
    53
    		Judging the Qualities of Things, Services, or People
  • Assessing the value, importance, or quality of things or people.
    		•
    53
    		Monitor Processes, Materials, or Surroundings
  • Monitoring and reviewing information from materials, events, or the environment, to detect or assess problems.
    		•
    50
    		Training and Teaching Others
  • Identifying the educational needs of others, developing formal educational or training programs or classes, and teaching or instructing others.
    		•
    49
    		Coaching and Developing Others
  • Identifying the developmental needs of others and coaching, mentoring, or otherwise helping others to improve their knowledge or skills.
    		•
    47
    		Interacting With Computers
  • Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.
    		•
    46
    		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.
    		•
    41
    		Selling or Influencing Others
  • Convincing others to buy merchandise/goods or to otherwise change their minds or actions.
    		•
    40
    		Guiding, Directing, and Motivating Subordinates
  • Providing guidance and direction to subordinates, including setting performance standards and monitoring performance.
    		•
    31
    		Monitoring and Controlling Resources
  • Monitoring and controlling resources and overseeing the spending of money.
    		•
    31
    		Staffing Organizational Units
  • Recruiting, interviewing, selecting, hiring, and promoting employees in an organization.
    		•
    31
    		Inspecting Equipment, Structures, or Material
  • Inspecting equipment, structures, or materials to identify the cause of errors or other problems or defects.
    		•
    26
    		Assisting and Caring for Others
  • Providing personal assistance, medical attention, emotional support, or other personal care to others such as coworkers, customers, or patients.
    		•
    16
    		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
    		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.
    		•
    16
    		Handling and Moving Objects
  • Using hands and arms in handling, installing, positioning, and moving materials, and manipulating things.
    		•
    10
    		Controlling Machines and Processes
  • Using either control mechanisms or direct physical activity to operate machines or processes (not including computers or vehicles).
    		•
    9
    		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.
    		•
    7
    		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.
    		•
    6
    		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.
    		•
    5
    		Operating Vehicles, Mechanized Devices, or Equipment
  • Running, maneuvering, navigating, or driving vehicles or mechanized equipment, such as forklifts, passenger vehicles, aircraft, or water craft.
    		•
    
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