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.
Sample of reported job titles:
Drug Regulatory Affairs Specialist, Regulatory Affairs Analyst (RA Analyst), Regulatory Affairs Associate (RA Associate), Regulatory Affairs Consultant (RA Consultant), Regulatory Affairs Specialist (RA Specialist), Regulatory Affairs Strategist (RA Strategist), Regulatory Engineer, Regulatory Services Consultant, Regulatory Specialist, Regulatory Submissions Associate
Occupation-Specific Information
Tasks
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
Technology Skills
- Accounting software:Fund accounting software,Tax software
- Analytical or scientific software:Analyse-it,Statistical software
- Business intelligence and data analysis software:MicroStrategy,Qlik Tech QlikView
- Cloud-based data access and sharing software:Microsoft SharePoint
- Data base management system software:Relational database management software
Occupational Requirements
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 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.
- Working with Computers:Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.
Detailed Work Activities
- Advise others on legal or regulatory compliance matters.
- Analyze data to identify or resolve operational problems.
- Analyze environmental regulations to ensure organizational compliance.
- Communicate with government agencies.
- Compile technical information or documentation.
Work Context
- Electronic Mail:95% responded"Every day"
- Spend Time Sitting:90% responded"Continually or almost continually"
- Indoors, Environmentally Controlled:79% responded"Every day"
- Physical Proximity:70% responded"Slightly close (e.g., shared office)"
- Structured versus Unstructured Work:55% responded"Some freedom"
Worker Requirements
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.
- Speaking:Talking to others to convey information effectively.
- Writing:Communicating effectively in writing as appropriate for the needs of the audience.
- 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.
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.
Education
How much education does a new hire need to perform a job in this occupation? Respondents said:
- 80%Bachelor's Degree
- 10%Master's Degree
Worker Characteristics
Abilities
- 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.
- Deductive Reasoning:The ability to apply general rules to specific problems to produce answers that make sense.
Interests
- Conventional:Conventional occupations frequently involve following set procedures and routines. These occupations can include working with data and details more than with ideas. Usually there is a clear line of authority to follow.
- Enterprising:Enterprising occupations frequently involve starting up and carrying out projects. These occupations can involve leading people and making many decisions. Sometimes they require risk taking and often deal with business.
Work Values
- Independence:Occupations that satisfy this work value allow employees to work on their own and make decisions. Corresponding needs are Creativity, Responsibility and Autonomy.
- 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.
- 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.
Work Styles
- Attention to Detail:Job requires being careful about detail and thorough in completing work tasks.
- Integrity:Job requires being honest and ethical.
- Dependability:Job requires being reliable, responsible, and dependable, and fulfilling obligations.
- Cooperation:Job requires being pleasant with others on the job and displaying a good-natured, cooperative attitude.
- Analytical Thinking:Job requires analyzing information and using logic to address work-related issues and problems.
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