How to become a Regulatory Affairs Specialist 2024

Regulatory Affairs Specialist 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.

Regulatory Affairs Specialist is Also Know as

In different settings, Regulatory Affairs Specialist is titled as

Drug Regulatory Affairs Specialist
Regulatory Affairs Analyst (RA Analyst)
Regulatory Affairs Associate (RA Associate)
Regulatory Affairs Consultant (RA Consultant)
Regulatory Affairs Specialist (RA Specialist)
Regulatory Affairs Strategist (RA Strategist)
Regulatory Engineer
Regulatory Services Consultant
Regulatory Specialist
Regulatory Submissions Associate

Education and Training of Regulatory Affairs Specialist

Regulatory Affairs Specialist is categorized in Job Zone Four: Considerable Preparation Needed

Experience Required for Regulatory Affairs Specialist

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 Required for Regulatory Affairs Specialist

Most of these occupations require a four-year bachelor's degree, but some do not.

Degrees Related to Regulatory Affairs Specialist

Training Required for Regulatory Affairs Specialist

Employees in these occupations usually need several years of work-related experience, on-the-job training, and/or vocational training.

Related Ocuupations

Some Ocuupations related to Regulatory Affairs Specialist in different industries are

What Do Regulatory Affairs Specialist do?

Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
Coordinate, prepare, or review regulatory submissions for domestic or international projects.
Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
Compile and maintain regulatory documentation databases or systems.
Coordinate efforts associated with the preparation of regulatory documents or submissions.
Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
Develop or conduct employee regulatory training.
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
Participate in internal or external audits.
Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
Prepare or maintain technical files as necessary to obtain and sustain product approval.
Recommend changes to company procedures in response to changes in regulations or standards.
Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
Review clinical protocols to ensure collection of data needed for regulatory submissions.
Write or update standard operating procedures, work instructions, or policies.
Coordinate recall or market withdrawal activities as necessary.
Develop or track quality metrics.
Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related 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.
Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.
Identify relevant guidance documents, international standards, or consensus standards.
Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
Recommend adjudication of product complaints.

Qualities of Good Regulatory Affairs Specialist

Written Comprehension: The ability to read and understand information and ideas presented in writing.
Written Expression: The ability to communicate information and ideas in writing so others will understand.
Oral Expression: The ability to communicate information and ideas in speaking so others will understand.
Oral Comprehension: The ability to listen to and understand information and ideas presented through spoken words and sentences.
Speech Clarity: The ability to speak clearly so others can understand you.
Inductive Reasoning: The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events).
Deductive Reasoning: The ability to apply general rules to specific problems to produce answers that make sense.
Problem Sensitivity: The ability to tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing that there is a problem.
Speech Recognition: The ability to identify and understand the speech of another person.
Information Ordering: The ability to arrange things or actions in a certain order or pattern according to a specific rule or set of rules (e.g., patterns of numbers, letters, words, pictures, mathematical operations).
Near Vision: The ability to see details at close range (within a few feet of the observer).
Fluency of Ideas: The ability to come up with a number of ideas about a topic (the number of ideas is important, not their quality, correctness, or creativity).
Category Flexibility: The ability to generate or use different sets of rules for combining or grouping things in different ways.
Mathematical Reasoning: The ability to choose the right mathematical methods or formulas to solve a problem.
Originality: The ability to come up with unusual or clever ideas about a given topic or situation, or to develop creative ways to solve a problem.
Far Vision: The ability to see details at a distance.
Selective Attention: The ability to concentrate on a task over a period of time without being distracted.
Perceptual Speed: The ability to quickly and accurately compare similarities and differences among sets of letters, numbers, objects, pictures, or patterns. The things to be compared may be presented at the same time or one after the other. This ability also includes comparing a presented object with a remembered object.
Flexibility of Closure: The ability to identify or detect a known pattern (a figure, object, word, or sound) that is hidden in other distracting material.
Memorization: The ability to remember information such as words, numbers, pictures, and procedures.
Speed of Closure: The ability to quickly make sense of, combine, and organize information into meaningful patterns.
Number Facility: The ability to add, subtract, multiply, or divide quickly and correctly.
Visualization: The ability to imagine how something will look after it is moved around or when its parts are moved or rearranged.
Time Sharing: The ability to shift back and forth between two or more activities or sources of information (such as speech, sounds, touch, or other sources).
Finger Dexterity: The ability to make precisely coordinated movements of the fingers of one or both hands to grasp, manipulate, or assemble very small objects.
Auditory Attention: The ability to focus on a single source of sound in the presence of other distracting sounds.
Hearing Sensitivity: The ability to detect or tell the differences between sounds that vary in pitch and loudness.
Visual Color Discrimination: The ability to match or detect differences between colors, including shades of color and brightness.
Depth Perception: The ability to judge which of several objects is closer or farther away from you, or to judge the distance between you and an object.
Trunk Strength: The ability to use your abdominal and lower back muscles to support part of the body repeatedly or continuously over time without "giving out" or fatiguing.
Wrist-Finger Speed: The ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
Dynamic Flexibility: The ability to quickly and repeatedly bend, stretch, twist, or reach out with your body, arms, and/or legs.
Spatial Orientation: The ability to know your location in relation to the environment or to know where other objects are in relation to you.
Sound Localization: The ability to tell the direction from which a sound originated.
Glare Sensitivity: The ability to see objects in the presence of a glare or bright lighting.
Peripheral Vision: The ability to see objects or movement of objects to one's side when the eyes are looking ahead.
Night Vision: The ability to see under low-light conditions.
Arm-Hand Steadiness: The ability to keep your hand and arm steady while moving your arm or while holding your arm and hand in one position.
Manual Dexterity: The ability to quickly move your hand, your hand together with your arm, or your two hands to grasp, manipulate, or assemble objects.
Gross Body Equilibrium: The ability to keep or regain your body balance or stay upright when in an unstable position.
Gross Body Coordination: The ability to coordinate the movement of your arms, legs, and torso together when the whole body is in motion.
Extent Flexibility: The ability to bend, stretch, twist, or reach with your body, arms, and/or legs.
Stamina: The ability to exert yourself physically over long periods of time without getting winded or out of breath.
Dynamic Strength: The ability to exert muscle force repeatedly or continuously over time. This involves muscular endurance and resistance to muscle fatigue.
Explosive Strength: The ability to use short bursts of muscle force to propel oneself (as in jumping or sprinting), or to throw an object.
Static Strength: The ability to exert maximum muscle force to lift, push, pull, or carry objects.
Speed of Limb Movement: The ability to quickly move the arms and legs.
Reaction Time: The ability to quickly respond (with the hand, finger, or foot) to a signal (sound, light, picture) when it appears.
Rate Control: The ability to time your movements or the movement of a piece of equipment in anticipation of changes in the speed and/or direction of a moving object or scene.
Response Orientation: The ability to choose quickly between two or more movements in response to two or more different signals (lights, sounds, pictures). It includes the speed with which the correct response is started with the hand, foot, or other body part.
Multilimb Coordination: The ability to coordinate two or more limbs (for example, two arms, two legs, or one leg and one arm) while sitting, standing, or lying down. It does not involve performing the activities while the whole body is in motion.
Control Precision: The ability to quickly and repeatedly adjust the controls of a machine or a vehicle to exact positions.

Tools Used by Regulatory Affairs Specialist

Computer data input scanners
Desktop computers
Laptop computers
Laser facsimile machines
Multi-line telephone systems
Personal computers
Photocopying equipment

Technology Skills required for Regulatory Affairs Specialist

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
Microsoft Access
Microsoft Dynamics
Microsoft Excel
Microsoft Office software
Microsoft Outlook
Microsoft PowerPoint
Microsoft Project
Microsoft SharePoint
Microsoft SQL Server
Microsoft Visio
Microsoft Visual Basic
Microsoft Word
MicroStrategy
NortonLifeLock cybersecurity software
Qlik Tech QlikView
Relational database management software
SAP software
Statistical software
Structured query language SQL
Tax software
Web browser software
Yardi software

US Universities

How to become Regulatory Affairs Specialist in 2024