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Careers / Regulatory Affairs Specialists |
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Summary Description |
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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. |
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Sample Job Titles |
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Clinical Quality Assurance Associate |
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Clinical Quality Assurance Specialist |
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Drug Regulatory Affairs Specialist |
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Product Safety Specialist |
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Quality Assurance Documentation Coordinator |
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Quality Assurance Documentation Specialist |
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7. |
Quality Assurance Specialist |
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8. |
Quality Assurance/Regulatory Affairs Specialist (QA/RA Specialist) |
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Regulatory Affairs Analyst |
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Regulatory Affairs Associate |
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11. |
Regulatory Affairs Consultant |
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Regulatory Affairs Coordinator |
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13. |
Regulatory Affairs Specialist |
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14. |
Regulatory Affairs Strategy Specialist |
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Regulatory Analyst |
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16. |
Regulatory Associate |
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17. |
Regulatory Compliance Specialist |
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18. |
Regulatory Services Consultant |
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19. |
Regulatory Specialist |
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20. |
Regulatory Submissions Associate |
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21. |
Research Compliance Specialist |
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22. |
Research Quality Assurance Analyst |
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23. |
Research Quality Assurance Specialist |
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Job Tasks |
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Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Prepare regulatory or compliance documentation.
- Coordinate regulatory documentation activities.
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Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Coordinate regulatory documentation activities.
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Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
- Examine product information to ensure compliance with regulations.
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Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Update knowledge of legal or regulatory environments.
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Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Explain regulations, policies, or procedures.
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Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
- Evaluate applicable laws and regulations to determine impact on organizational activities.
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Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
- Advise others on legal or regulatory compliance matters.
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Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Prepare regulatory or compliance documentation.
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Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Coordinate regulatory documentation activities.
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Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- Coordinate regulatory documentation activities.
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Analyze product complaints and make recommendations regarding their reportability.
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Coordinate recall or market withdrawal activities as necessary.
- Oversee business processes.
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Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
- Examine product information to ensure compliance with regulations.
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Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
- Communicate with government agencies.
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Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Obtain documentation to authorize activities.
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Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
- Evaluate applicable laws and regulations to determine impact on organizational activities.
- Advise others on legal or regulatory compliance matters.
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Review clinical protocols to ensure collection of data needed for regulatory submissions.
- Evaluate applicable laws and regulations to determine impact on organizational activities.
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Compile and maintain regulatory documentation databases or systems.
- Maintain data in information systems or databases.
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Recommend changes to company procedures in response to changes in regulations or standards.
- Advise others on legal or regulatory compliance matters.
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Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
- Update knowledge of legal or regulatory environments.
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Write or update standard operating procedures, work instructions, or policies.
- Establish organizational guidelines or policies.
- Prepare financial documents.
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Participate in internal or external audits.
- Examine financial records or processes.
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Develop or conduct employee regulatory training.
- Train personnel in organizational or compliance procedures.
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Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
- Oversee business processes.
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Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
- Correspond with customers to answer questions or resolve complaints.
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Develop or track quality metrics.
- Monitor business indicators.
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Work Activities |
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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. |
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Getting Information —
Observing, receiving, and otherwise obtaining information from all relevant sources. |
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Updating and Using Relevant Knowledge —
Keeping up-to-date technically and applying new knowledge to your job. |
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Interacting With Computers —
Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information. |
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Communicating with Supervisors, Peers, or Subordinates —
Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person. |
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Organizing, Planning, and Prioritizing Work —
Developing specific goals and plans to prioritize, organize, and accomplish your work. |
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Processing Information —
Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data. |
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Establishing and Maintaining Interpersonal Relationships —
Developing constructive and cooperative working relationships with others, and maintaining them over time. |
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Interpreting the Meaning of Information for Others —
Translating or explaining what information means and how it can be used. |
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Making Decisions and Solving Problems —
Analyzing information and evaluating results to choose the best solution and solve problems. |
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Documenting/Recording Information —
Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form. |
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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. |
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Identifying Objects, Actions, and Events —
Identifying information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events. |
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Analyzing Data or Information —
Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts. |
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Performing Administrative Activities —
Performing day-to-day administrative tasks such as maintaining information files and processing paperwork. |
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Developing Objectives and Strategies —
Establishing long-range objectives and specifying the strategies and actions to achieve them. |
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Provide Consultation and Advice to Others —
Providing guidance and expert advice to management or other groups on technical, systems-, or process-related topics. |
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Coordinating the Work and Activities of Others —
Getting members of a group to work together to accomplish tasks. |
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Developing and Building Teams —
Encouraging and building mutual trust, respect, and cooperation among team members. |
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Scheduling Work and Activities —
Scheduling events, programs, and activities, as well as the work of others. |
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Monitor Processes, Materials, or Surroundings —
Monitoring and reviewing information from materials, events, or the environment, to detect or assess problems. |
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Resolving Conflicts and Negotiating with Others —
Handling complaints, settling disputes, and resolving grievances and conflicts, or otherwise negotiating with others. |
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Training and Teaching Others —
Identifying the educational needs of others, developing formal educational or training programs or classes, and teaching or instructing others. |
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Judging the Qualities of Things, Services, or People —
Assessing the value, importance, or quality of things or people. |
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Thinking Creatively —
Developing, designing, or creating new applications, ideas, relationships, systems, or products, including artistic contributions. |
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Estimating the Quantifiable Characteristics of Products, Events, or Information —
Estimating sizes, distances, and quantities; or determining time, costs, resources, or materials needed to perform a work activity. |
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Coaching and Developing Others —
Identifying the developmental needs of others and coaching, mentoring, or otherwise helping others to improve their knowledge or skills. |
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Selling or Influencing Others —
Convincing others to buy merchandise/goods or to otherwise change their minds or actions. |
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Guiding, Directing, and Motivating Subordinates —
Providing guidance and direction to subordinates, including setting performance standards and monitoring performance. |
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Inspecting Equipment, Structures, or Material —
Inspecting equipment, structures, or materials to identify the cause of errors or other problems or defects. |
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Monitoring and Controlling Resources —
Monitoring and controlling resources and overseeing the spending of money. |
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Staffing Organizational Units —
Recruiting, interviewing, selecting, hiring, and promoting employees in an organization. |
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Interesting Fact |
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The U.S. industry expected to experience the greatest decline between 2002 and 2012 is Apparel Manufacturing. |
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Did you know... |
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MyPlan.com has a Video Library of nearly 500 different career and industry videos! |
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