Occupation Details
Regulatory Affairs Managers
Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
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Interests
Enterprising
Enterprising occupations frequently involve starting up and carrying out projects. These occupations can involve leading people and making many decisions. Sometimes they require risk taking and often deal with business.
Conventional
Conventional occupations frequently involve following set procedures and routines. These occupations can include working with data and details more than with ideas. Usually there is a clear line of authority to follow.
Work Values
Achievement
Occupations that satisfy this work value are results oriented and allow employees to use their strongest abilities, giving them a feeling of accomplishment. Corresponding needs are Ability Utilization and Achievement.
Support
Occupations that satisfy this work value offer supportive management that stands behind employees. Corresponding needs are Company Policies, Supervision: Human Relations and Supervision: Technical.
Independence
Occupations that satisfy this work value allow employees to work on their own and make decisions. Corresponding needs are Creativity, Responsibility and Autonomy.
Salary & Job Outlook
Starting Salary
$84,090.00
New York StateMedian Salary
$135,950.00
New York StateExperienced Salary
$194,710.00
New York StateNational Average for Comparison
New York State Job Market Outlook
Jobs Right Now (2018)
236,390
professionals in NYFuture Job Growth (2030)
276,430
+4,004 jobs/yearNew Jobs Every Year
24,663
new opportunities yearlyGrowth Rate
0.2%
projected increasePreparation: Experience, Training, and Education
The list below outlines the prior educational experience required to perform in this occupation.
Degree Needed - Four-year college
Experience Requirements
A considerable amount of work-related skill, knowledge, or experience is needed for these occupations. For example, an accountant must complete four years of college and work for several years in accounting to be considered qualified.
Education Requirements
Most of these occupations require a four-year bachelor's degree, but some do not.
Training Details
Employees in these occupations usually need several years of work-related experience, on-the-job training, and/or vocational training.
Transferrable Skills and Experience
Many of these occupations involve coordinating, supervising, managing, or training others. Examples include real estate brokers, sales managers, database administrators, graphic designers, conservation scientists, art directors, and cost estimators.
School Programs
The following lists school programs which are applicable to this occupation.
Licensing & Certification
State License and Certifications Requirements are not currently associated with this occupation.
Skills
The list below includes the skills required by workers in this occupation; skills are what allow you to learn more quickly and improve your performance.
Reading Comprehension
Understanding written sentences and paragraphs in work-related documents.
Writing
Communicating effectively in writing as appropriate for the needs of the audience.
Speaking
Talking to others to convey information effectively.
Critical Thinking
Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems.
Monitoring
Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.
Skill level is measured on a seven point scale, where one means 'some competence required for this occupation' and seven means 'a high level of expertise required for this occupation'.
Knowledge
The list below includes knowledge items, the principles and facts required by this occupation.
English Language
Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
Law and Government
Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.
Administration and Management
Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.
Biology
Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.
Education and Training
Knowledge of principles and methods for curriculum and training design, teaching and instruction for individuals and groups, and the measurement of training effects.
Administrative
Knowledge of administrative and office procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and workplace terminology.
Knowledge level is measured on a seven point scale, where one means 'some competence required for this occupation' and seven means 'a high level of expertise required for this occupation'.
Work Environment
The list below includes the physical and social factors that influence the nature of work in this occupation.
Hover over or tap each factor to see its description.
Work Styles
Included in the list below are the personal work style characteristics that can affect how well a worker is likely to perform in this occupation.
Adaptability/Flexibility
Job requires being open to change (positive or negative) and to considerable variety in the workplace.
Analytical Thinking
Job requires analyzing information and using logic to address work-related issues and problems.
Attention to Detail
Job requires being careful about detail and thorough in completing work tasks.
Cooperation
Job requires being pleasant with others on the job and displaying a good-natured, cooperative attitude.
Dependability
Job requires being reliable, responsible, and dependable, and fulfilling obligations.
Initiative
Job requires a willingness to take on responsibilities and challenges.
Integrity
Job requires being honest and ethical.
Leadership
Job requires a willingness to lead, take charge, and offer opinions and direction.
Persistence
Job requires persistence in the face of obstacles.
Stress Tolerance
Job requires accepting criticism and dealing calmly and effectively with high-stress situations.
Tools & Technology
This list below describes the machines, equipment, tools, software, and information technology that workers in this occupation will use.
Tools
- Computer laser printers
- Desktop computers
- Laptop computers
- Laser facsimile machines
- Multi-line telephone systems
- Personal computers
Technology
- Adobe Systems Adobe Acrobat
- Analyse-it
- Aris Global Register
- Axway eSubmissions
- Database software
- Datafarm eCTDViewer
- Dialog DialogLink
- Document publishing software
- GlobalSubmit VALIDATE
- IBM Notes
- Image Solutions eCTDXpress
- Integrated development environment IDE software
- Lorenz labelBridge
- MasterControl software
- MedXView eCTDauditor
- MediRegs Risk Assessment Manager
Duties
Job duties information is not available for this occupation.
Tasks
The list below outlines specific tasks that a worker in this occupation is called upon to do regularly.
- Provide responses to regulatory agencies regarding product information or issues.
- Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
- Develop regulatory strategies and implementation plans for the preparation and submission of new products.
- Manage activities such as audits, regulatory agency inspections, or product recalls.
- Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Maintain current knowledge of relevant regulations, including proposed and final rules.
- Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
- Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- Direct documentation efforts to ensure compliance with domestic and international regulations and standards.
- Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
- Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
- Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
- Train staff in regulatory policies or procedures.
- Develop and maintain standard operating procedures or local working practices.
- 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.
- Contribute to the development or implementation of business unit strategic and operating plans.
- Establish procedures or systems for publishing document submissions in hardcopy or electronic formats.
- Coordinate internal discoveries and depositions with legal department staff.
- Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.
- Establish regulatory priorities or budgets and allocate resources and workloads.
- Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates on electronic publishing of submissions.
- Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives.
- 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.