Occupation Details
Regulatory Affairs Specialists
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.
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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
Working Conditions
Occupations that satisfy this work value offer job security and good working conditions. Corresponding needs are Activity, Compensation, Independence, Security, Variety and Working Conditions.
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
$54,040.00
New York StateMedian Salary
$82,000.00
New York StateExperienced Salary
$105,200.00
New York StateNational Average for Comparison
New York State Job Market Outlook
Jobs Right Now (2018)
24,110
professionals in NYFuture Job Growth (2030)
28,380
+427 jobs/yearNew Jobs Every Year
2,457
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.
Apprenticeship
Contact your regional representative to learn more about apprenticeships available in your area by visiting Apprenticeship Contacts.
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.
Active Listening
Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
Writing
Communicating effectively in writing as appropriate for the needs of the audience.
Speaking
Talking to others to convey information effectively.
Reading Comprehension
Understanding written sentences and paragraphs in work-related documents.
Critical Thinking
Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems.
Judgment and Decision Making
Considering the relative costs and benefits of potential actions to choose the most appropriate one.
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.
Biology
Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.
Computers and Electronics
Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.
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.
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.
Achievement/Effort
Job requires establishing and maintaining personally challenging achievement goals and exerting effort toward mastering tasks.
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.
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 data input scanners
- Desktop computers
- Laptop computers
- Laser facsimile machines
- Multi-line telephone systems
- Personal computers
Technology
- Adobe Systems Adobe Acrobat
- Analyse-it
- Atrion Intelligent Authoring
- DataVision
- FileMaker Pro
- Fund accounting software
- Healthcare common procedure coding system HCPCS
- Human resource management software HRMS
- Integrated development environment IDE software
- LexisNexis
- McAfee
- Medical procedure coding software
- MicroStrategy
- Microsoft Access
- Microsoft Dynamics
- Microsoft Excel
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.
- 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.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Review clinical protocols to ensure collection of data needed for regulatory submissions.
- Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
- 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.
- Monitor national or international legislation on ozone-depleting substances or global warming.
- Obtain clearances for the use of recycled plastics in product packaging.