Gerentes de Asuntos Regulatorios
Planificar, dirigir o coordinar las actividades de producción de una organización para garantizar el cumplimiento de las regulaciones y procedimientos operativos estándar.
Herramientas tecnológicas
Tareas principales
- 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.
- Proporcionar orientación regulatoria a departamentos o equipos de proyectos de desarrollo con respecto al diseño, desarrollo, evaluación o comercialización de productos.
- Gestione actividades como auditorías, inspecciones de agencias reguladoras o retiradas de productos.
- Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
- Maintain current knowledge of relevant regulations, including proposed and final rules.
- Formular o implementar políticas y procedimientos de asuntos regulatorios para garantizar que se mantenga o mejore el cumplimiento normativo.
- Direct documentation efforts to ensure compliance with domestic and international regulations and standards.
- Revise materiales como literatura de marketing o manuales de usuario para garantizar que se cumplan los requisitos de la agencia reguladora.
- Participate in the development or implementation of clinical trial protocols.
- Implementar o monitorear sistemas de procesamiento de quejas para garantizar una resolución efectiva y oportuna de todas las investigaciones de quejas.
- Establish procedures or systems for publishing document submissions in hardcopy or electronic formats.
- Develop and maintain standard operating procedures or local working practices.
- Establecer prioridades regulatorias o presupuestos y asignar recursos y cargas de trabajo.
- Capacitar al personal en políticas o procedimientos regulatorios.
- Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives.
- Contribuir al desarrollo o implementación de planes estratégicos y operativos de la unidad de negocio.
- Coordinate internal discoveries and depositions with legal department staff.
- Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
- Desarrollar relaciones con agencias reguladoras ambientales estatales o federales para conocer y analizar los impactos potenciales de las regulaciones de política ambiental propuestas.
- 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.
- Evaluar nuevos sistemas de publicación de software y consultar con agencias reguladoras sobre noticias o actualizaciones sobre la publicación electrónica de envíos.
Habilidades
Conocimiento
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Capacidades
Actividades laborales
Contexto laboral
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%
Educación
Bachelor's degree
Master's degree
Some college, no degree
Intereses
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
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
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,
Estilos de trabajo
Valores laborales
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