US Universities

100K US Universities, Schools and Colleges

How to become Regulatory Affairs Manager in 2024

Regulatory Affairs Manager Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.

Regulatory Affairs Manager is Also Know as

In different settings, Regulatory Affairs Manager is titled as

  • Global Regulatory Affairs Director (Global RA Director)
  • Global Regulatory Affairs Manager (Global RA Manager)
  • Regulatory Affairs Director (RA Director)
  • Regulatory Affairs Manager (RA Manager)
  • Regulatory Affairs Quality Assurance Director (RA QA Director)
  • Regulatory Director
  • Regulatory Science Director

Education and Training of Regulatory Affairs Manager

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

Experience Required for Regulatory Affairs Manager

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 Manager

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

Degrees Related to Regulatory Affairs Manager

Training Required for Regulatory Affairs Manager

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 Manager in different industries are

What Do Regulatory Affairs Manager do?

  • Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
  • Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
  • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
  • Develop regulatory strategies and implementation plans for the preparation and submission of new products.
  • Establish regulatory priorities or budgets and allocate resources and workloads.
  • Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
  • Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
  • Maintain current knowledge of relevant regulations, including proposed and final rules.
  • Manage activities such as audits, regulatory agency inspections, or product recalls.
  • Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
  • Participate in the development or implementation of clinical trial protocols.
  • 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.
  • Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
  • Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
  • Train staff in regulatory policies or procedures.
  • Contribute to the development or implementation of business unit strategic and operating plans.
  • Coordinate internal discoveries and depositions with legal department staff.
  • Develop and maintain standard operating procedures or local working practices.
  • Establish procedures or systems for publishing document submissions in hardcopy or electronic formats.
  • Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates on electronic publishing of submissions.
  • Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.
  • Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation.
  • Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives.
  • Monitor regulatory affairs trends related to environmental issues.
  • Direct documentation efforts to ensure compliance with domestic and international regulations and standards.

Qualities of Good Regulatory Affairs Manager

  • Written Comprehension: The ability to read and understand information and ideas presented in writing.
  • Oral Expression: The ability to communicate information and ideas in speaking so others will understand.
  • Written Expression: The ability to communicate information and ideas in writing 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.
  • 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.
  • Inductive Reasoning: The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events).
  • Near Vision: The ability to see details at close range (within a few feet of the observer).
  • 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).
  • Speech Recognition: The ability to identify and understand the speech of another person.
  • 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).
  • 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.
  • Category Flexibility: The ability to generate or use different sets of rules for combining or grouping things in different ways.
  • 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.
  • 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.
  • Selective Attention: The ability to concentrate on a task over a period of time without being distracted.
  • 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).
  • Number Facility: The ability to add, subtract, multiply, or divide quickly and correctly.
  • Speed of Closure: The ability to quickly make sense of, combine, and organize information into meaningful patterns.
  • Mathematical Reasoning: The ability to choose the right mathematical methods or formulas to solve a problem.
  • Far Vision: The ability to see details at a distance.
  • Memorization: The ability to remember information such as words, numbers, pictures, and procedures.
  • Visualization: The ability to imagine how something will look after it is moved around or when its parts are moved or rearranged.
  • Auditory Attention: The ability to focus on a single source of sound in the presence of other distracting sounds.
  • Visual Color Discrimination: The ability to match or detect differences between colors, including shades of color and brightness.
  • 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.
  • 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.
  • Hearing Sensitivity: The ability to detect or tell the differences between sounds that vary in pitch and loudness.
  • 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.
  • Dynamic Strength: The ability to exert muscle force repeatedly or continuously over time. This involves muscular endurance and resistance to muscle fatigue.
  • Wrist-Finger Speed: The ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
  • 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.
  • 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.
  • Control Precision: The ability to quickly and repeatedly adjust the controls of a machine or a vehicle to exact positions.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Dynamic Flexibility: The ability to quickly and repeatedly bend, stretch, twist, or reach out with your body, arms, and/or legs.
  • 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.
  • Reaction Time: The ability to quickly respond (with the hand, finger, or foot) to a signal (sound, light, picture) when it appears.
  • 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.

Tools Used by Regulatory Affairs Manager

  • Computer laser printers
  • Desktop computers
  • Laptop computers
  • Laser facsimile machines
  • Multi-line telephone systems
  • Personal computers
  • Photocopying equipment

Technology Skills required for Regulatory Affairs Manager

  • Adlib Express
  • Adobe Acrobat
  • Analyse-it
  • Aris Global Register
  • Axway eSubmissions
  • Database software
  • Datafarm a-Pulse
  • Datafarm eCTDGatekeeper
  • Datafarm eCTDViewer
  • Datafarm S-Cubed
  • Dialog DialogLink
  • Document publishing software
  • DoubleBridge ROSETTA Phoenix eCTD Viewer
  • DoubleBridge ROSETTA Pyramid
  • DoubleBridge ROSETTA Sceptre
  • DoubleBridge ROSETTA Scribe
  • Electronic common technical document eCTD software
  • Electronic common technical document eCTD validating software
  • Electronic common technical document eCTD viewing software
  • Electronic document management system EDMS
  • Enterprise content management ECM software
  • Extedo DOCvalidator
  • Extedo eCTDmanager Suite
  • Extedo PLmanager
  • GlobalSubmit REVIEW
  • GlobalSubmit VALIDATE
  • IBM Notes
  • Image Solutions eCTDXpress
  • Image Solutions ISIPublisher
  • Integrated development environment IDE software
  • Lorenz DocuBridge
  • Lorenz eValidator
  • Lorenz labelBridge
  • MasterControl software
  • MediRegs E-dition Compliance Monitor
  • MediRegs Pharmaceutical Regulation Suite
  • MediRegs Regulation and Reimbursement Suite
  • MediRegs Risk Assessment Manager
  • MedXView eCTDauditor
  • Microsoft Access
  • Microsoft Excel
  • Microsoft Office software
  • Microsoft Outlook
  • Microsoft PowerPoint
  • Microsoft Project
  • Microsoft SharePoint
  • Microsoft Visio
  • Microsoft Windows
  • Microsoft Word
  • Octagon StartingPoint
  • Octagon ViewPoint eCTD Complete
  • Pilgrim Regulatory Submission
  • Risk management software
  • Samarind RMS
  • SAP EHS Management
  • SAP software
  • Software development tools
  • Spreadsheet software
  • Statistical analysis software
  • Structured query language SQL
  • Tableau
  • Take Solutions PharmaReady Document Management System
  • Thomson Reuters Liquent CoreDossier Submission Accelerator for eCTD
  • Thomson Reuters Liquent InSight Suite
  • Total quality management TQM software
  • Virtify eCTD
  • Web browser software
  • Word processing software
  • XML authoring software