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11-9199.01 Perspectivas brilhantes

Regulatory Affairs Managers

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Tarefas principais

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

Habilidades

Writing
81%
Reading Comprehension
78%
Active Listening
75%
Speaking
75%
Critical Thinking
72%
Complex Problem Solving
69%
Judgment and Decision Making
69%
Systems Analysis
69%
Systems Evaluation
69%
Monitoring
66%
Time Management
66%
Active Learning
63%
Coordination
63%
Instructing
56%
Social Perceptiveness
56%
Learning Strategies
50%
Management of Personnel Resources
50%
Negotiation
50%
Persuasion
50%
Service Orientation
47%
Operations Analysis
44%
Mathematics
35%
Science
35%
Management of Financial Resources
28%
Management of Material Resources
25%
Operations Monitoring
22%
Programming
22%
Technology Design
16%
Quality Control Analysis
6%
Equipment Maintenance
0%
Equipment Selection
0%
Installation
0%
Operation and Control
0%
Repairing
0%
Troubleshooting
0%

Conhecimento

English Language
89%
Law and Government
74%
Administration and Management
68%
Biology
60%
Education and Training
52%
Administrative
51%
Chemistry
51%
Computers and Electronics
48%
Mathematics
44%
Medicine and Dentistry
44%
Production and Processing
41%
Design
39%
Engineering and Technology
39%
Personnel and Human Resources
37%
Customer and Personal Service
32%
Public Safety and Security
32%
Communications and Media
27%
Physics
27%
Sales and Marketing
26%
Foreign Language
24%
Mechanical
24%
Psychology
23%
Economics and Accounting
21%
Telecommunications
20%
Sociology and Anthropology
18%
Building and Construction
14%
Geography
13%
Therapy and Counseling
12%
Transportation
11%
Food Production
10%
Philosophy and Theology
7%
History and Archeology
4%
Fine Arts
2%

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Aptidões

Written Expression
81%
Oral Comprehension
78%
Oral Expression
78%
Written Comprehension
78%
Deductive Reasoning
72%
Inductive Reasoning
72%
Near Vision
69%
Problem Sensitivity
69%
Speech Clarity
69%
Speech Recognition
69%
Information Ordering
66%
Fluency of Ideas
53%
Category Flexibility
50%
Originality
50%
Flexibility of Closure
47%
Selective Attention
47%
Far Vision
44%
Perceptual Speed
41%
Speed of Closure
41%
Time Sharing
41%
Mathematical Reasoning
35%
Number Facility
35%
Memorization
31%
Auditory Attention
25%
Hearing Sensitivity
25%
Visual Color Discrimination
25%
Visualization
25%
Trunk Strength
22%
Depth Perception
13%
Wrist-Finger Speed
13%
Finger Dexterity
10%
Dynamic Strength
6%
Arm-Hand Steadiness
0%
Control Precision
0%
Dynamic Flexibility
0%
Explosive Strength
0%
Extent Flexibility
0%
Glare Sensitivity
0%
Gross Body Coordination
0%
Gross Body Equilibrium
0%
Manual Dexterity
0%
Multilimb Coordination
0%
Night Vision
0%
Peripheral Vision
0%
Rate Control
0%
Reaction Time
0%
Response Orientation
0%
Sound Localization
0%
Spatial Orientation
0%
Speed of Limb Movement
0%
Stamina
0%
Static Strength
0%

Atividades de trabalho

Evaluating Information to Determine Compliance with Standards
92%
Communicating with People Outside the Organization
91%
Communicating with Supervisors, Peers, or Subordinates
90%
Interpreting the Meaning of Information for Others
90%
Getting Information
88%
Making Decisions and Solving Problems
87%
Updating and Using Relevant Knowledge
86%
Working with Computers
84%
Documenting/Recording Information
83%
Identifying Objects, Actions, and Events
82%
Processing Information
82%
Analyzing Data or Information
81%
Establishing and Maintaining Interpersonal Relationships
81%
Developing Objectives and Strategies
76%
Organizing, Planning, and Prioritizing Work
74%
Providing Consultation and Advice to Others
66%
Coaching and Developing Others
63%
Developing and Building Teams
63%
Resolving Conflicts and Negotiating with Others
63%
Thinking Creatively
63%
Training and Teaching Others
63%
Guiding, Directing, and Motivating Subordinates
60%
Coordinating the Work and Activities of Others
59%
Monitoring Processes, Materials, or Surroundings
57%
Scheduling Work and Activities
57%
Judging the Qualities of Objects, Services, or People
56%
Estimating the Quantifiable Characteristics of Products, Events, or Information
50%
Performing Administrative Activities
50%
Selling or Influencing Others
50%
Staffing Organizational Units
46%
Monitoring and Controlling Resources
43%
Inspecting Equipment, Structures, or Materials
30%
Assisting and Caring for Others
28%
Performing for or Working Directly with the Public
17%
Performing General Physical Activities
15%
Drafting, Laying Out, and Specifying Technical Devices, Parts, and Equipment
11%
Controlling Machines and Processes
10%
Handling and Moving Objects
7%
Repairing and Maintaining Electronic Equipment
4%
Operating Vehicles, Mechanized Devices, or Equipment
2%
Repairing and Maintaining Mechanical Equipment
1%

Contexto de trabalho

E-Mail

How frequently does your job require you to use E-mail?

100%

Spend Time Sitting

How much does this job require sitting?

91%

Work With or Contribute to a Work Group or Team

How important is it to work with or contribute to a work group or team in this job?

91%

Face-to-Face Discussions with Individuals and Within Teams

How frequently does your job require face-to-face discussions with individuals and within teams?

90%

Telephone Conversations

How often do you have telephone conversations in this job?

88%

Importance of Being Exact or Accurate

How important is being very exact or highly accurate in performing this job?

84%

Duration of Typical Work Week

Number of hours typically worked in one week.

81%

Indoors, Environmentally Controlled

How often does this job require working indoors in an environmentally controlled environment (like a warehouse with air conditioning)?

81%

Contact With Others

How much does this job require the worker to be in contact with others (face-to-face, by telephone, or otherwise) in order to perform it?

79%

Coordinate or Lead Others in Accomplishing Work Activities

How important is it to coordinate or lead others (not as a supervisor or team leader) in accomplishing work activities in this job?

76%

Determine Tasks, Priorities and Goals

How much freedom does the worker have in determining the tasks, priorities, or goals of the job?

76%

Impact of Decisions on Co-workers or Company Results

What results do your decisions usually have on other people or the image or reputation or financial resources of your employer?

76%

Freedom to Make Decisions

How much decision making freedom, without supervision, does the job offer?

74%

Time Pressure

How often does this job require the worker to meet strict deadlines?

66%

Frequency of Decision Making

How often is the worker required to make decisions that affect other people, the financial resources, and/or the image and reputation of the organization?

65%

Work Outcomes and Results of Other Workers

How responsible is the worker for work outcomes and results of other workers?

61%

Written Letters and Memos

How frequently does your job require written letters and memos?

61%

Level of Competition

To what extent does this job require the worker to compete or to be aware of competitive pressures?

58%

Importance of Repeating Same Tasks

How important are continuous, repetitive, physical activities (like key entry) or mental activities (like checking entries in a ledger) to performing this job?

56%

Conflict Situations

How frequently are there conflict situations the employee has to face in this job?

49%

Consequence of Error

How serious would the result usually be if the worker made a mistake that was not easily correctable?

48%

Spend Time Making Repetitive Motions

How much does this job require making repetitive motions?

47%

Physical Proximity

To what extent does this job require the worker to perform job tasks physically close to other people?

43%

Public Speaking

How frequently does your job require public speaking (one speaker with an audience)?

36%

Dealing With Unpleasant, Angry, or Discourteous People

How frequently does the worker have to deal with unpleasant, angry, or discourteous individuals as part of the job requirements?

34%

Deal With External Customers or the Public in General

How important is it to deal with external customers (as in retail sales) or the public in general (as in police work) in this job?

33%

Degree of Automation

How automated is the job?

25%

Health and Safety of Other Workers

How much responsibility is there for the health and safety of others in this job?

23%

Spend Time Standing

How much does this job require standing?

15%

Wear Common Protective or Safety Equipment such as Safety Shoes, Glasses, Gloves, Hearing Protection, Hard Hats, or Life Jackets

How often does this job require wearing common protective or safety equipment such as safety shoes, glasses, gloves, hearing protection, hard hats or life-jackets?

14%

Spend Time Using Your Hands to Handle, Control, or Feel Objects, Tools, or Controls

How much does this job require using your hands to handle, control, or feel objects, tools or controls?

13%

Exposed to Sounds, Noise Levels that are Distracting or Uncomfortable

How often does this job require working exposed to sounds and noise levels that are distracting or uncomfortable?

11%

Exposed to Contaminants

How often does this job require working exposed to contaminants (such as pollutants, gases, dust or odors)?

9%

Spend Time Walking or Running

How much does this job require walking or running?

9%

Wear Specialized Protective or Safety Equipment such as Breathing Apparatus, Safety Harness, Full Protection Suits, or Radiation Protection

How often does this job require wearing specialized protective or safety equipment such as breathing apparatus, safety harness, full protection suits, or radiation protection?

8%

Exposed to Hazardous Conditions

How often does this job require exposure to hazardous conditions?

7%

Indoors, Not Environmentally Controlled

How often does this job require working in an environment that is not environmentally controlled (like a warehouse without air conditioning)?

7%

Work Schedules

How regular are the work schedules for this job?

7%

Exposed to Disease or Infections

How often does this job require exposure to disease/infections?

6%

Exposed to Hazardous Equipment

How often does this job require exposure to hazardous equipment?

6%

In an Enclosed Vehicle or Operate Enclosed Equipment

How often does this job require working in a closed vehicle or operate enclosed equipment (like a car)?

4%

Dealing with Violent or Physically Aggressive People

How frequently does this job require the worker to deal with physical aggression of violent individuals?

3%

Exposed to Extremely Bright or Inadequate Lighting Conditions

How often does this job require working in extremely bright or inadequate lighting conditions?

3%

Spend Time Bending or Twisting Your Body

How much does this job require bending or twisting your body?

3%

Exposed to Cramped Work Space, Awkward Positions

How often does this job require working in cramped work spaces that requires getting into awkward positions?

2%

Exposed to Radiation

How often does this job require exposure to radiation?

2%

Exposed to Very Hot or Cold Temperatures

How often does this job require working in very hot (above 90 F degrees) or very cold (below 32 F degrees) temperatures?

2%

Spend Time Climbing Ladders, Scaffolds, or Poles

How much does this job require climbing ladders, scaffolds, poles, etc.?

2%

Exposed to High Places

How often does this job require exposure to high places?

1%

Exposed to Minor Burns, Cuts, Bites, or Stings

How often does this job require exposure to minor burns, cuts, bites, or stings?

1%

Outdoors, Exposed to All Weather Conditions

How often does this job require working outdoors, exposed to all weather conditions?

1%

Outdoors, Under Cover

How often does this job require working outdoors, under cover (like in an open shed)?

1%

Spend Time Kneeling, Crouching, Stooping, or Crawling

How much does this job require kneeling, crouching, stooping or crawling?

1%

Exposed to Whole Body Vibration

How often does this job require exposure to whole body vibration (like operating a jackhammer or earth moving equipment)?

0%

In an Open Vehicle or Operating Equipment

How often does this job require working in an open vehicle or operating equipment (like a tractor)?

0%

Pace Determined by Speed of Equipment

How important is it to this job that the pace is determined by the speed of equipment or machinery? (This does not refer to keeping busy at all times on this job.)

0%

Spend Time Keeping or Regaining Balance

How much does this job require keeping or regaining your balance?

0%

Educação

Bachelor's degree

74%

Master's degree

13%

Some college, no degree

4%

Interesses

Enterprising

Work involves managing, negotiating, marketing, or selling, typically in a business setting, or leading or advising people in political and legal situations. Enterprising occupations are often associated with business initiatives, sales, marketing/advertis

90

Conventional

Work involves following procedures and regulations to organize information or data, typically in a business setting. Conventional occupations are often associated with office work, accounting, mathematics/statistics, information technology, finance, or hum

84

Investigative

Work involves studying and researching non-living objects, living organisms, disease or other forms of impairment, or human behavior. Investigative occupations are often associated with physical, life, medical, or social sciences, and can be found in the f

31

Social

Work involves helping, teaching, advising, assisting, or providing service to others. Social occupations are often associated with social, health care, personal service, teaching/education, or religious activities.

27

Realistic

Work involves designing, building, or repairing of equipment, materials, or structures, engaging in physical activity, or working outdoors. Realistic occupations are often associated with engineering, mechanics and electronics, construction, woodworking, t

13

Artistic

Work involves creating original visual artwork, performances, written works, food, or music for a variety of media, or applying artistic principles to the design of various objects and materials. Artistic occupations are often associated with visual arts,

4

Estilos de trabalho

Attention to Detail
100%
Dependability
98%
Integrity
98%
Cautiousness
91%
Leadership Orientation
77%
Intellectual Curiosity
75%
Achievement Orientation
72%
Perseverance
66%
Initiative
61%
Self-Control
61%
Stress Tolerance
60%
Adaptability
58%
Self-Confidence
58%
Cooperation
54%
Tolerance for Ambiguity
44%
Sincerity
42%
Social Orientation
39%
Innovation
29%
Optimism
23%
Humility
22%
Empathy
15%

Valores profissionais

Achievement
67%
Independence
67%
Support
61%
Working Conditions
61%
Recognition
56%
Relationships
56%

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