Regulatory Affairs Specialists

Personality

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Job Outlook:

None

Education: Bachelor's degree Details

Education Details

80%

Bachelor's Degree

10%

Master's Degree

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.

Post-Doctoral Training

Salary

High: $118,060.00

Average: $76,980.00

Hourly

Average: $37.01

Summary of What they do:

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.

Responsibilities

Obtain documentation to authorize activities.

Prepare regulatory or compliance documentation.

Coordinate regulatory documentation activities.

Explain regulations, policies, or procedures.

Coordinate regulatory documentation activities.

Examine product information to ensure compliance with regulations.

Advise others on legal or regulatory compliance matters.

Maintain data in information systems or databases.

Coordinate regulatory documentation activities.

Evaluate applicable laws and regulations to determine impact on organizational activities.

Train personnel in organizational or compliance procedures.

Update knowledge of legal or regulatory environments.

Examine financial records or processes.

Coordinate regulatory documentation activities.

Prepare regulatory or compliance documentation.

Advise others on legal or regulatory compliance matters.

Correspond with customers to answer questions or resolve complaints.

Evaluate applicable laws and regulations to determine impact on organizational activities.

Establish organizational guidelines or policies.

Prepare financial documents.

Oversee business processes.

Monitor business indicators.

Oversee business processes.

Examine product information to ensure compliance with regulations.

Analyze environmental regulations to ensure organizational compliance.

Obtain documentation to authorize activities.

Update knowledge of legal or regulatory environments.

Compile technical information or documentation.

Review documents or materials for compliance with policies or regulations.

Evaluate applicable laws and regulations to determine impact on organizational activities.

Communicate with government agencies.

Investigate system, equipment, or product failures.

Analyze data to identify or resolve operational problems.

Recommend changes or corrective procedures.

Tasks On The Job

Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
Compile and maintain regulatory documentation databases or systems.
Coordinate efforts associated with the preparation of regulatory documents or submissions.
Coordinate, prepare, or review regulatory submissions for domestic or international projects.
Coordinate recall or market withdrawal activities as necessary.
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.
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.
Develop or track quality metrics.
Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
Identify relevant guidance documents, international standards, or consensus standards.
Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
Monitor national or international legislation on ozone-depleting substances or global warming.
Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
Obtain clearances for the use of recycled plastics in product packaging.
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.
Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
Recommend adjudication of product complaints.
Recommend changes to company procedures in response to changes in regulations or standards.
Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
Review clinical protocols to ensure collection of data needed for regulatory submissions.
Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.
Write or update standard operating procedures, work instructions, or policies.

PERSONALITY

KEY:

Strength

Caution

Warning

Your Assessment Results		CAREER CHARACTERISTICS Importance


? ? ? ? Begin Career Assessment	94%	Attention to Detail - Job requires being careful about detail and thorough in completing work tasks.
? ? ? ? Begin Career Assessment	90%	Integrity - Job requires being honest and ethical.
? ? ? ? Begin Career Assessment	84%	Dependability - Job requires being reliable, responsible, and dependable, and fulfilling obligations.
? ? ? ? Begin Career Assessment	80%	Cooperation - Job requires being pleasant with others on the job and displaying a good-natured, cooperative attitude.
? ? ? ? Begin Career Assessment	75%	Persistence - Job requires persistence in the face of obstacles.
? ? ? ? Begin Career Assessment	75%	Analytical Thinking - Job requires analyzing information and using logic to address work-related issues and problems.
? ? ? ? Begin Career Assessment	74%	Achievement/Effort - Job requires establishing and maintaining personally challenging achievement goals and exerting effort toward mastering tasks.
? ? ? ? Begin Career Assessment	73%	Stress Tolerance - Job requires accepting criticism and dealing calmly and effectively with high-stress situations.
? ? ? ? Begin Career Assessment	71%	Initiative - Job requires a willingness to take on responsibilities and challenges.
? ? ? ? Begin Career Assessment	66%	Adaptability/Flexibility - Job requires being open to change (positive or negative) and to considerable variety in the workplace.
? ? ? ? Begin Career Assessment	63%	Leadership - Job requires a willingness to lead, take charge, and offer opinions and direction.
? ? ? ? Begin Career Assessment	61%	Independence - Job requires developing one's own ways of doing things, guiding oneself with little or no supervision, and depending on oneself to get things done.
? ? ? ? Begin Career Assessment	59%	Self-Control - Job requires maintaining composure, keeping emotions in check, controlling anger, and avoiding aggressive behavior, even in very difficult situations.
? ? ? ? Begin Career Assessment	56%	Innovation - Job requires creativity and alternative thinking to develop new ideas for and answers to work-related problems.

Your Assessment Results		IMPORTANT STRENGTHS Importance


? ? ? ? Begin Career Assessment		89%	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.
? ? ? ? Begin Career Assessment		78%	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.

Your Assessment Results		WORK VALUES Importance


? ? ? ? Begin Career Assessment	61%	Working Conditions - Occupations that satisfy this work value offer job security and good working conditions. Corresponding needs are Activity, Compensation, Independence, Security, Variety and Working Conditions.
? ? ? ? Begin Career Assessment	61%	Independence - Occupations that satisfy this work value allow employees to work on their own and make decisions. Corresponding needs are Creativity, Responsibility and Autonomy.
? ? ? ? Begin Career Assessment	56%	Achievement - Occupations that satisfy this work value are results oriented and allow employees to use their strongest abilities, giving them a feeling of accomplishment. Corresponding needs are Ability Utilization and Achievement.
? ? ? ? Begin Career Assessment	56%	Support - Occupations that satisfy this work value offer supportive management that stands behind employees. Corresponding needs are Company Policies, Supervision: Human Relations and Supervision: Technical.

APTITUDES

KEY:

Strength

Caution

Warning

Your Assessment Results		ABILITIES \| SKILLS Importance


? ? ? ? Begin Career Assessment	81%	Written Comprehension - The ability to read and understand information and ideas presented in writing.
? ? ? ? Begin Career Assessment	78%	Written Expression - The ability to communicate information and ideas in writing so others will understand.
? ? ? ? Begin Career Assessment	75%	Oral Comprehension - The ability to listen to and understand information and ideas presented through spoken words and sentences.
? ? ? ? Begin Career Assessment	75%	Oral Expression - The ability to communicate information and ideas in speaking so others will understand.
? ? ? ? Begin Career Assessment	72%	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.
? ? ? ? Begin Career Assessment	72%	Deductive Reasoning - The ability to apply general rules to specific problems to produce answers that make sense.
? ? ? ? Begin Career Assessment	72%	Inductive Reasoning - The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events).
? ? ? ? Begin Career Assessment	72%	Speech Clarity - The ability to speak clearly so others can understand you.
? ? ? ? Begin Career Assessment	69%	Speech Recognition - The ability to identify and understand the speech of another person.
? ? ? ? Begin Career Assessment	68%	Reading Comprehension - Understanding written sentences and paragraphs in work-related documents.
? ? ? ? Begin Career Assessment	66%	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).
? ? ? ? Begin Career Assessment	66%	Near Vision - The ability to see details at close range (within a few feet of the observer).
? ? ? ? Begin Career Assessment	61%	Critical Thinking - Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems.
? ? ? ? Begin Career Assessment	59%	Writing - Communicating effectively in writing as appropriate for the needs of the audience.
? ? ? ? Begin Career Assessment	59%	Speaking - Talking to others to convey information effectively.
? ? ? ? Begin Career Assessment	59%	Judgment and Decision Making - Considering the relative costs and benefits of potential actions to choose the most appropriate one.
? ? ? ? Begin Career Assessment	57%	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.
? ? ? ? Begin Career Assessment	57%	Systems Analysis - Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes.
? ? ? ? Begin Career Assessment	55%	Active Learning - Understanding the implications of new information for both current and future problem-solving and decision-making.
? ? ? ? Begin Career Assessment	55%	Coordination - Adjusting actions in relation to others' actions.
? ? ? ? Begin Career Assessment	55%	Complex Problem Solving - Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
? ? ? ? Begin Career Assessment	55%	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.
? ? ? ? Begin Career Assessment	54%	Monitoring - Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.
? ? ? ? Begin Career Assessment	54%	Persuasion - Persuading others to change their minds or behavior.
? ? ? ? Begin Career Assessment	53%	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).

Your Assessment Results		TASKS \| ACTIVITIES Importance


? ? ? ? Begin Career Assessment	91%	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.
? ? ? ? Begin Career Assessment	90%	Getting Information - Observing, receiving, and otherwise obtaining information from all relevant sources.
? ? ? ? Begin Career Assessment	86%	Communicating with Supervisors, Peers, or Subordinates - Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
? ? ? ? Begin Career Assessment	83%	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.
? ? ? ? Begin Career Assessment	81%	Working with Computers - Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.
? ? ? ? Begin Career Assessment	81%	Making Decisions and Solving Problems - Analyzing information and evaluating results to choose the best solution and solve problems.
? ? ? ? Begin Career Assessment	80%	Interpreting the Meaning of Information for Others - Translating or explaining what information means and how it can be used.
? ? ? ? Begin Career Assessment	80%	Updating and Using Relevant Knowledge - Keeping up-to-date technically and applying new knowledge to your job.
? ? ? ? Begin Career Assessment	79%	Establishing and Maintaining Interpersonal Relationships - Developing constructive and cooperative working relationships with others, and maintaining them over time.
? ? ? ? Begin Career Assessment	76%	Organizing, Planning, and Prioritizing Work - Developing specific goals and plans to prioritize, organize, and accomplish your work.
? ? ? ? Begin Career Assessment	76%	Analyzing Data or Information - Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.
? ? ? ? Begin Career Assessment	71%	Developing Objectives and Strategies - Establishing long-range objectives and specifying the strategies and actions to achieve them.
? ? ? ? Begin Career Assessment	70%	Resolving Conflicts and Negotiating with Others - Handling complaints, settling disputes, and resolving grievances and conflicts, or otherwise negotiating with others.
? ? ? ? Begin Career Assessment	69%	Providing Consultation and Advice to Others - Providing guidance and expert advice to management or other groups on technical, systems-, or process-related topics.
? ? ? ? Begin Career Assessment	69%	Documenting/Recording Information - Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.
? ? ? ? Begin Career Assessment	68%	Coordinating the Work and Activities of Others - Getting members of a group to work together to accomplish tasks.
? ? ? ? Begin Career Assessment	64%	Scheduling Work and Activities - Scheduling events, programs, and activities, as well as the work of others.
? ? ? ? Begin Career Assessment	64%	Developing and Building Teams - Encouraging and building mutual trust, respect, and cooperation among team members.
? ? ? ? Begin Career Assessment	62%	Processing Information - Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.
? ? ? ? Begin Career Assessment	61%	Identifying Objects, Actions, and Events - Identifying information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events.
? ? ? ? Begin Career Assessment	56%	Performing Administrative Activities - Performing day-to-day administrative tasks such as maintaining information files and processing paperwork.
? ? ? ? Begin Career Assessment	56%	Training and Teaching Others - Identifying the educational needs of others, developing formal educational or training programs or classes, and teaching or instructing others.
? ? ? ? Begin Career Assessment	54%	Judging the Qualities of Objects, Services, or People - Assessing the value, importance, or quality of things or people.
? ? ? ? Begin Career Assessment	51%	Coaching and Developing Others - Identifying the developmental needs of others and coaching, mentoring, or otherwise helping others to improve their knowledge or skills.

Your Assessment Results		CONTEXT \| ATTRIBUTES Importance


? ? ? ? Begin Career Assessment	99%	Electronic Mail - How often do you use electronic mail in this job?
? ? ? ? Begin Career Assessment	98%	Spend Time Sitting - How much does this job require sitting?
? ? ? ? Begin Career Assessment	87%	Indoors, Environmentally Controlled - How often does this job require working indoors in environmentally controlled conditions?
? ? ? ? Begin Career Assessment	86%	Work With Work Group or Team - How important is it to work with others in a group or team in this job?
? ? ? ? Begin Career Assessment	86%	Telephone - How often do you have telephone conversations in this job?
? ? ? ? Begin Career Assessment	86%	Face-to-Face Discussions - How often do you have to have face-to-face discussions with individuals or teams in this job?
? ? ? ? Begin Career Assessment	80%	Contact With Others - How much does this job require the worker to be in contact with others (face-to-face, by telephone, or otherwise) in order to perform it?
? ? ? ? Begin Career Assessment	79%	Importance of Being Exact or Accurate - How important is being very exact or highly accurate in performing this job?
? ? ? ? Begin Career Assessment	73%	Structured versus Unstructured Work - To what extent is this job structured for the worker, rather than allowing the worker to determine tasks, priorities, and goals?
? ? ? ? Begin Career Assessment	70%	Freedom to Make Decisions - How much decision making freedom, without supervision, does the job offer?
? ? ? ? Begin Career Assessment	69%	Time Pressure - How often does this job require the worker to meet strict deadlines?
? ? ? ? Begin Career Assessment	65%	Letters and Memos - How often does the job require written letters and memos?
? ? ? ? Begin Career Assessment	64%	Coordinate or Lead Others - How important is it to coordinate or lead others in accomplishing work activities in this job?
? ? ? ? Begin Career Assessment	61%	Impact of Decisions on Co-workers or Company Results - What results do your decisions usually have on other people or the image or reputation or financial resources of your employer?
? ? ? ? Begin Career Assessment	58%	Importance of Repeating Same Tasks - How important is repeating the same physical activities (e.g., key entry) or mental activities (e.g., checking entries in a ledger) over and over, without stopping, to performing this job?
? ? ? ? Begin Career Assessment	55%	Physical Proximity - To what extent does this job require the worker to perform job tasks in close physical proximity to other people?
? ? ? ? Begin Career Assessment	54%	Frequency of Decision Making - How frequently is the worker required to make decisions that affect other people, the financial resources, and/or the image and reputation of the organization?
? ? ? ? Begin Career Assessment	73%	Duration of Typical Work Week - Number of hours typically worked in one week.