13-1041.07Apprenticeship

Regulatory Affairs Specialists

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Key Tasks

  • Coordinate efforts associated with the preparation of regulatory documents or submissions.
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
  • Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  • Prepare or maintain technical files as necessary to obtain and sustain product approval.
  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
  • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
  • Coordinate recall or market withdrawal activities as necessary.
  • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
  • Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
  • Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
  • Identify relevant guidance documents, international standards, or consensus standards.
  • Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
  • Review clinical protocols to ensure collection of data needed for regulatory submissions.
  • Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Recommend changes to company procedures in response to changes in regulations or standards.
  • Participate in internal or external audits.
  • Compile and maintain regulatory documentation databases or systems.
  • Write or update standard operating procedures, work instructions, or policies.
  • Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
  • Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
  • Develop or track quality metrics.
  • Develop or conduct employee regulatory training.
  • Recommend adjudication of product complaints.
  • Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
  • Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
  • Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.
  • Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
  • Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.
  • Develop regulatory strategies for products.

Skills

Active Listening
75%
Speaking
75%
Writing
75%
Critical Thinking
72%
Judgment and Decision Making
72%
Reading Comprehension
72%
Complex Problem Solving
69%
Systems Analysis
69%
Social Perceptiveness
60%
Time Management
60%
Active Learning
56%
Monitoring
56%
Systems Evaluation
56%
Coordination
53%
Negotiation
53%
Instructing
50%
Learning Strategies
50%
Persuasion
50%
Service Orientation
50%
Management of Personnel Resources
47%
Operations Analysis
41%
Mathematics
38%
Management of Financial Resources
28%
Quality Control Analysis
28%
Management of Material Resources
25%
Operations Monitoring
25%
Programming
22%
Science
22%
Technology Design
22%
Equipment Maintenance
0%
Equipment Selection
0%
Installation
0%
Operation and Control
0%
Repairing
0%
Troubleshooting
0%

Knowledge

English Language
88%
Law and Government
78%
Biology
61%
Computers and Electronics
60%
Administration and Management
59%
Administrative
54%
Chemistry
45%
Medicine and Dentistry
45%
Communications and Media
41%
Education and Training
40%
Engineering and Technology
40%
Production and Processing
40%
Mathematics
39%
Customer and Personal Service
36%
Telecommunications
26%
Design
25%
Foreign Language
25%
Public Safety and Security
25%
Personnel and Human Resources
21%
Sales and Marketing
21%
Geography
19%
Psychology
17%
Physics
16%
Economics and Accounting
12%
Mechanical
11%
Sociology and Anthropology
11%
Transportation
8%
Food Production
6%
Therapy and Counseling
5%
History and Archeology
4%
Philosophy and Theology
4%
Building and Construction
3%
Fine Arts
0%

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Abilities

Written Comprehension
81%
Written Expression
78%
Oral Comprehension
75%
Oral Expression
75%
Deductive Reasoning
72%
Inductive Reasoning
72%
Problem Sensitivity
72%
Speech Clarity
72%
Speech Recognition
69%
Information Ordering
66%
Near Vision
66%
Fluency of Ideas
53%
Category Flexibility
50%
Mathematical Reasoning
50%
Far Vision
47%
Flexibility of Closure
47%
Originality
47%
Perceptual Speed
47%
Selective Attention
47%
Memorization
41%
Speed of Closure
41%
Number Facility
38%
Visualization
35%
Finger Dexterity
31%
Time Sharing
31%
Auditory Attention
28%
Hearing Sensitivity
25%
Visual Color Discrimination
25%
Depth Perception
22%
Trunk Strength
16%
Wrist-Finger Speed
6%
Arm-Hand Steadiness
0%
Control Precision
0%
Dynamic Flexibility
0%
Dynamic Strength
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%

Work Activities

Evaluating Information to Determine Compliance with Standards
91%
Getting Information
90%
Communicating with Supervisors, Peers, or Subordinates
86%
Communicating with People Outside the Organization
83%
Making Decisions and Solving Problems
81%
Working with Computers
81%
Interpreting the Meaning of Information for Others
80%
Updating and Using Relevant Knowledge
80%
Establishing and Maintaining Interpersonal Relationships
79%
Analyzing Data or Information
76%
Organizing, Planning, and Prioritizing Work
76%
Developing Objectives and Strategies
71%
Resolving Conflicts and Negotiating with Others
70%
Documenting/Recording Information
69%
Providing Consultation and Advice to Others
69%
Coordinating the Work and Activities of Others
68%
Developing and Building Teams
64%
Scheduling Work and Activities
64%
Processing Information
62%
Identifying Objects, Actions, and Events
61%
Performing Administrative Activities
56%
Training and Teaching Others
56%
Judging the Qualities of Objects, Services, or People
54%
Coaching and Developing Others
51%
Guiding, Directing, and Motivating Subordinates
49%
Selling or Influencing Others
48%
Thinking Creatively
48%
Estimating the Quantifiable Characteristics of Products, Events, or Information
45%
Monitoring Processes, Materials, or Surroundings
42%
Monitoring and Controlling Resources
36%
Staffing Organizational Units
36%
Inspecting Equipment, Structures, or Materials
29%
Assisting and Caring for Others
21%
Performing for or Working Directly with the Public
16%
Drafting, Laying Out, and Specifying Technical Devices, Parts, and Equipment
13%
Performing General Physical Activities
10%
Controlling Machines and Processes
9%
Handling and Moving Objects
6%
Repairing and Maintaining Electronic Equipment
6%
Repairing and Maintaining Mechanical Equipment
4%
Operating Vehicles, Mechanized Devices, or Equipment
3%

Work Context

E-Mail

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

99%

Spend Time Sitting

How much does this job require sitting?

98%

Indoors, Environmentally Controlled

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

87%

Face-to-Face Discussions with Individuals and Within Teams

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

86%

Telephone Conversations

How often do you have telephone conversations in this job?

86%

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?

86%

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?

80%

Importance of Being Exact or Accurate

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

79%

Determine Tasks, Priorities and Goals

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

73%

Duration of Typical Work Week

Number of hours typically worked in one week.

73%

Freedom to Make Decisions

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

70%

Time Pressure

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

69%

Written Letters and Memos

How frequently does your job require written letters and memos?

65%

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?

64%

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?

61%

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?

58%

Physical Proximity

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

55%

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?

54%

Level of Competition

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

50%

Spend Time Making Repetitive Motions

How much does this job require making repetitive motions?

50%

Conflict Situations

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

46%

Work Outcomes and Results of Other Workers

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

46%

Consequence of Error

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

45%

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?

38%

Public Speaking

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

35%

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%

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?

25%

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?

23%

Spend Time Standing

How much does this job require standing?

19%

Degree of Automation

How automated is the job?

18%

Health and Safety of Other Workers

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

15%

Spend Time Walking or Running

How much does this job require walking or running?

11%

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)?

9%

Exposed to Contaminants

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

8%

Work Schedules

How regular are the work schedules for this job?

8%

Dealing with Violent or Physically Aggressive People

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

7%

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.)

6%

Exposed to Minor Burns, Cuts, Bites, or Stings

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

5%

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?

5%

Exposed to Cramped Work Space, Awkward Positions

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

4%

Exposed to Extremely Bright or Inadequate Lighting Conditions

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

4%

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%

Spend Time Bending or Twisting Your Body

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

3%

Exposed to Disease or Infections

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

1%

Exposed to Radiation

How often does this job require exposure to radiation?

1%

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?

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 Keeping or Regaining Balance

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

1%

Exposed to Hazardous Conditions

How often does this job require exposure to hazardous conditions?

0%

Exposed to Hazardous Equipment

How often does this job require exposure to hazardous equipment?

0%

Exposed to High Places

How often does this job require exposure to high places?

0%

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%

Spend Time Climbing Ladders, Scaffolds, or Poles

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

0%

Spend Time Kneeling, Crouching, Stooping, or Crawling

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

0%

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?

0%

Education

Bachelor's degree

80%

Master's degree

10%

Post-baccalaureate certificate

5%

Interests

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

89

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

58

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

39

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.

24

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

8

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,

0

Work Styles

Attention to Detail
100%
Dependability
88%
Cautiousness
87%
Integrity
85%
Intellectual Curiosity
73%
Achievement Orientation
60%
Cooperation
56%
Perseverance
54%
Initiative
48%
Self-Confidence
48%
Stress Tolerance
48%
Self-Control
46%
Adaptability
41%
Sincerity
33%
Leadership Orientation
29%
Social Orientation
29%
Humility
20%
Tolerance for Ambiguity
13%
Empathy
11%
Optimism
9%
Innovation
8%

Work Values

Independence
61%
Working Conditions
61%
Achievement
56%
Support
56%
Recognition
50%
Relationships
50%

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