Projected Growth: Average
Projected Job Openings
Considerable Preparation Needed
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:
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.
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.
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.
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.
Multi-line telephone systems
Laser facsimile machines
Computer data input scanners
Adobe Systems Adobe Acrobat
Healthcare common procedure coding system HCPCS
Integrated development environment IDE software
Microsoft SQL Server
Qlik Tech QlikView
Relational database management softwareAll Technologies
Atrion Intelligent Authoring
Fund accounting software
Human resource management software HRMS
Medical procedure coding software
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.
Communicating effectively in writing as appropriate for the needs of the audience.
Talking to others to convey information effectively.
Understanding written sentences and paragraphs in work related documents.
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.
Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes.
Being aware of others' reactions and understanding why they react as they do.
Managing one's own time and the time of others.
Understanding the implications of new information for both current and future problem-solving and decision-making.
Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.
Identifying measures or indicators of system performance and the actions needed to improve or correct performance, relative to the goals of the system.
Adjusting actions in relation to others' actions.
Bringing others together and trying to reconcile differences.
Selecting and using training/instructional methods and procedures appropriate for the situation when learning or teaching new things.
Persuading others to change their minds or behavior.
Teaching others how to do something.
Actively looking for ways to help people.
Read and understand information and ideas presented in writing.
Cognitive Abilities › Verbal Abilities › Written Comprehension
Communicate information and ideas in writing so others will understand.
Cognitive Abilities › Verbal Abilities › Written Expression
Listen to and understand information and ideas presented through spoken words and sentences.
Cognitive Abilities › Verbal Abilities › Oral Comprehension
Communicate information and ideas in speaking so others will understand.
Cognitive Abilities › Verbal Abilities › Oral Expression
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 › Problem Sensitivity
Apply general rules to specific problems to produce answers that make sense.
Cognitive Abilities › Idea Generation and Reasoning Abilities › Deductive Reasoning
See details at close range (within a few feet of the observer).
Sensory Abilities › Visual Abilities › Near Vision