Regulatory Affairs Specialists
What is a Regulatory Affairs Specialist?
A Regulatory Affairs Specialist is a professional responsible for ensuring that companies comply with all of the regulations and laws pertaining to their business. This role is particularly vital in industries such as pharmaceuticals, biotechnology, medical devices, and food safety, where regulations can be complex and subject to frequent changes. Specialists are tasked with preparing and submitting documentation to regulatory agencies, including applications for new products, research protocols, and advertising materials. They also keep abreast of legislative developments and communicate these changes to their organizations to maintain compliance. By acting as a liaison between the company and regulatory bodies, Regulatory Affairs Specialists play a critical role in the product development process, ensuring that new products meet the necessary standards before reaching the market. Their expertise helps to safeguard public health while also protecting their companies from potential legal and financial repercussions associated with non-compliance.
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.
Technology Skills
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Data base user interface and query software
- Microsoft Access
- Microsoft SQL Server
- Structured query language SQL
- Yardi software
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Presentation software
- Microsoft PowerPoint
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Medical software
- Healthcare common procedure coding system HCPCS
- Medical procedure coding software
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Accounting software
- Fund accounting software
- Tax software
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Document management software
- Adobe Acrobat
- Atrion Intelligent Authoring
Tools Used
- Photocopiers
- Scanners
- Notebook computers
- Special purpose telephones
- Laser fax machine
Knowledge
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English Language
Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
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Law and Government
Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.
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Biology
Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.
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Computers and Electronics
Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.
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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.
Skills
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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.
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Speaking
Talking to others to convey information effectively.
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Writing
Communicating effectively in writing as appropriate for the needs of the audience.
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Critical Thinking
Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems.
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Judgment and Decision Making
Considering the relative costs and benefits of potential actions to choose the most appropriate one.
Abilities
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Written Comprehension
The ability to read and understand information and ideas presented in writing.
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Written Expression
The ability to communicate information and ideas in writing so others will understand.
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Oral Comprehension
The ability to listen to and understand information and ideas presented through spoken words and sentences.
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Oral Expression
The ability to communicate information and ideas in speaking so others will understand.
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Deductive Reasoning
The ability to apply general rules to specific problems to produce answers that make sense.
Education
How much education does a new hire need to perform a job in this occupation?
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Bachelor's degree
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Master's degree
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Post-baccalaureate certificate
Awarded for completion of an organized program of study; designed for people who have completed a Baccalaureate degree, but do not meet the requirements of academic degrees carrying the title of Master
Work Activities
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Evaluating Information to Determine Compliance with Standards
Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards.
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Getting Information
Observing, receiving, and otherwise obtaining information from all relevant sources.
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Communicating with Supervisors, Peers, or Subordinates
Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
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Communicating with People Outside the Organization
Communicating with people outside the organization, representing the organization to customers, the public, government, and other external sources. This information can be exchanged in person, in writing, or by telephone or e-mail.
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Making Decisions and Solving Problems
Analyzing information and evaluating results to choose the best solution and solve problems.
Detailed Work Activities
- Coordinate regulatory documentation activities.
- Obtain documentation to authorize activities.
- Prepare regulatory or compliance documentation.
- Evaluate applicable laws and regulations to determine impact on organizational activities.
- Explain regulations, policies, or procedures.
Work Interests
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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 human resources.
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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/advertising, finance, management/administration, professional advising, public speaking, politics, or law.
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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 fields of humanities, mathematics/statistics, information technology, or health care service.

Job Outlook
Projected salary and job growth
$43790.0 - $123710.0
New job opportunities are likely in the future. : Average
Assessment
Related assessments and tests
No assessment available.