Regulatory Affairs Specialists

Government & Public Administration > Governance

Projected Growth: Average

30700+
Projected Job Openings

Considerable Preparation Needed

Job Description

Your job is to 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.

Common job titles of Regulatory Affairs Specialists include:
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Experience and Education

A considerable amount of work-related skill, knowledge, or experience is needed for this occupation. For example, a person in this occupation must complete four years of college and work for several years in industry to be considered qualified.

  • 80% said they needed a Bachelor's Degree.

  • 10% said they needed a Master's Degree.

Tasks & Responsibilities

Wondering what Regulatory Affairs Specialists REALLY do throughout a day at work? Perhaps you should know what you’ll be doing all day before pursuing a career. So here are some tasks that Regulatory Affairs Specialists can be found doing during the work day. Hover over each task for information about relevance and importance. Scroll further to find a list of other careers that have similar tasks.


Essential Tasks

    Coordinate efforts associated with the preparation of regulatory documents or submissions.

    Compile and maintain regulatory documentation databases or systems.

    Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.


Regular Tasks

    Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.

    Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.

    Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.

    Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.

    Coordinate, prepare, or review regulatory submissions for domestic or international projects.

    Recommend adjudication of product complaints.

    Identify relevant guidance documents, international standards, or consensus standards.

    Prepare or maintain technical files as necessary to obtain and sustain product approval.

    Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.

    Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.

    Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.

    Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.


Occasional Tasks

    Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.

    Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.

    Obtain clearances for the use of recycled plastics in product packaging.

    Direct the collection and preparation of laboratory samples as requested by regulatory agencies.

    Develop or track quality metrics.

    Write or update standard operating procedures, work instructions, or policies.

    Review clinical protocols to ensure collection of data needed for regulatory submissions.

    Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.

    Recommend changes to company procedures in response to changes in regulations or standards.

    Participate in internal or external audits.

    Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.

    Develop or conduct employee regulatory training.

    Monitor national or international legislation on ozone-depleting substances or global warming.

    Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.

    Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.

    Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.

    Coordinate recall or market withdrawal activities as necessary.

What Tools and Technologies do Regulatory Affairs Specialists use?

The future of work is gonna be… techy🤖. No matter the career path, you’ll have to understand what the experts use to get the job done. Employers want to see practical experience with these tools and technologies. Use these lists to figure out what tools you need to learn and see trends about up and coming tech. Scroll further to find a list of other careers that use similar tools.

Tools

Photocopying equipment

Personal computers

Multi-line telephone systems

Laser facsimile machines

Laptop computers

Desktop computers

Computer data input scanners

Technologies

Adobe Systems Adobe Acrobat

Healthcare common procedure coding system HCPCS

Integrated development environment IDE software

Microsoft SharePoint

Microsoft SQL Server

Qlik Tech QlikView

Relational database management software

All Technologies

Symantec

Yardi

Analyse-it

Atrion Intelligent Authoring

DataVision

FileMaker Pro

Fund accounting software

Human resource management software HRMS

LexisNexis

McAfee

Medical procedure coding software

What Skills Do Regulatory Affairs Specialists Need to Have?

Let’s be real… take a look in the mirror! Do you have the what it takes to join the other Regulatory Affairs Specialists? The Skills? The Ability to succeed? If so, and you enjoy using these skills, then this job is for you. If not, GOOD NEWS, you can always pick up a new skill if you’re willing to put in the effort 💪

Skills

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.

Complex Problem Solving

Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.

Systems Analysis

Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes.

Social Perceptiveness

Being aware of others' reactions and understanding why they react as they do.

Time Management

Managing one's own time and the time of others.

Active Learning

Understanding the implications of new information for both current and future problem-solving and decision-making.

Monitoring

Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.

Systems Evaluation

Identifying measures or indicators of system performance and the actions needed to improve or correct performance, relative to the goals of the system.

Coordination

Adjusting actions in relation to others' actions.

Negotiation

Bringing others together and trying to reconcile differences.

Learning Strategies

Selecting and using training/instructional methods and procedures appropriate for the situation when learning or teaching new things.

Persuasion

Persuading others to change their minds or behavior.

Instructing

Teaching others how to do something.

Service Orientation

Actively looking for ways to help people.

Abilities

Cognitive Abilities › Verbal Abilities › Written Comprehension

Read and understand information and ideas presented in writing.

Cognitive Abilities › Verbal Abilities › Written Expression

Communicate information and ideas in writing so others will understand.

Cognitive Abilities › Verbal Abilities › Oral Comprehension

Listen to and understand information and ideas presented through spoken words and sentences.

Cognitive Abilities › Verbal Abilities › Oral Expression

Communicate information and ideas in speaking so others will understand.

Cognitive Abilities › Idea Generation and Reasoning Abilities › Problem Sensitivity

Tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing there is a problem.

Cognitive Abilities › Idea Generation and Reasoning Abilities › Deductive Reasoning

Apply general rules to specific problems to produce answers that make sense.

Sensory Abilities › Visual Abilities › Near Vision

See details at close range (within a few feet of the observer).

Everything Regulatory Affairs Specialists Should Know…

Regulatory Affairs Specialists typically have vast knowledge of the subjects below. Think about this a lot… if you’re not a fan of the subjects, chances are this career isn’t for you. But, there’s plenty of time to learn and continue to learn throughout your career 🎓

Knowledge

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.

Clerical

Knowledge of administrative and clerical procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and other office procedures and terminology.

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