Regulatory Affairs Specialist

Also called: Clinical Quality Assurance Associate, Clinical Quality Assurance Specialist, Drug Regulatory Affairs Specialist, Product Safety Specialist, Quality Assurance Documentation Coordinator

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Regulatory affairs specialists 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.

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

Work Context

Electronic Mail — 95% responded "Every day".
Spend Time Sitting — 90% responded "Continually or almost continually".
Indoors, Environmentally Controlled — 79% responded "Every day".
Work With Work Group or Team — 50% responded "Extremely important".
Telephone — 48% responded "Once a week or more but not every day".
Face-to-Face Discussions — 53% responded "Every day".
Contact With Others — 45% responded "Constant contact with others".

Work Activities

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.
Getting Information — Observing, receiving, and otherwise obtaining information from all relevant sources.
Communicating with Supervisors, Peers, or Subordinates — Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
Communicating with Persons Outside 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.
Interacting With Computers — Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.
Making Decisions and Solving Problems — Analyzing information and evaluating results to choose the best solution and solve problems.
Interpreting the Meaning of Information for Others — Translating or explaining what information means and how it can be used.
Updating and Using Relevant Knowledge — Keeping up-to-date technically and applying new knowledge to your job.

Establishing and Maintaining Interpersonal Relationships — Developing constructive and cooperative working relationships with others, and maintaining them over time.

Analyzing Data or Information — Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.

Organizing, Planning, and Prioritizing Work — Developing specific goals and plans to prioritize, organize, and accomplish your work.

Developing Objectives and Strategies — Establishing long-range objectives and specifying the strategies and actions to achieve them.

Resolving Conflicts and Negotiating with Others — Handling complaints, settling disputes, and resolving grievances and conflicts, or otherwise negotiating with others.

Provide Consultation and Advice to Others — Providing guidance and expert advice to management or other groups on technical, systems-, or process-related topics.

Documenting/Recording Information — Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.

Coordinating the Work and Activities of Others — Getting members of a group to work together to accomplish tasks.

Developing and Building Teams — Encouraging and building mutual trust, respect, and cooperation among team members.

Scheduling Work and Activities — Scheduling events, programs, and activities, as well as the work of others.

Processing Information — Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.

Identifying Objects, Actions, and Events — Identifying information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events.

Training and Teaching Others — Identifying the educational needs of others, developing formal educational or training programs or classes, and teaching or instructing others.

Performing Administrative Activities — Performing day-to-day administrative tasks such as maintaining information files and processing paperwork.

Judging the Qualities of Things, Services, or People — Assessing the value, importance, or quality of things or people.

Coaching and Developing Others — Identifying the developmental needs of others and coaching, mentoring, or otherwise helping others to improve their knowledge or skills.

Detailed Work Activities

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.

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.

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.

Systems Analysis

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

Complex Problem Solving

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

Time Management

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

Social Perceptiveness

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

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.

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.

Negotiation

Bringing others together and trying to reconcile differences.

Coordination

Adjusting actions in relation to others' actions.

Service Orientation

Actively looking for ways to help people.

Instructing

Teaching others how to do something.

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.

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 Comprehension

The ability to listen to and understand information and ideas presented through spoken words and sentences.

Oral Expression

The ability to communicate information and ideas in speaking so others will understand.

People interested in this work like activities that include ideas, thinking, and figuring things out.

They do well at jobs that need:

Achievement/Effort

Persistence

Initiative

Leadership

Cooperation

Concern for Others

Social Orientation

Self Control

You might use software like this on the job:

Document management software

Adobe Systems Adobe Acrobat
Atrion Intelligent Authoring

Presentation software

Microsoft PowerPoint

Project management software

Microsoft Project
Microsoft SharePoint

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Regulatory Affairs Specialist

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