Regulatory Affairs Specialists
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
Knowledge
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Abilities
Work Activities
Work Context
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
Master's degree
Post-baccalaureate certificate
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
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
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
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.
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
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,
Work Styles
Work Values
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