Assessment Template For 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.
Regulatory Affairs Specialists

Tests

Qustom Questions

Hiring success rate

icon chart bar

89% hiring better

Test Used

icon chart bar

12618 times

Popular Job Roles
Drug Regulatory Affairs SpecialistRegulatory 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 EngineerRegulatory Services ConsultantRegulatory SpecialistRegulatory Submissions Associate

Occupation-Specific

Technology Skills
Data base user interface and query software
Questions20
Time Limit20 min

Tasks

  • 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.

Technology Skills

Data base user interface and query software

Microsoft Access, Microsoft SQL Server, Structured query language SQL, Yardi software

Presentation software

Microsoft PowerPoint

Medical software

Healthcare common procedure coding system HCPCS, Medical procedure coding software

Accounting software

Fund accounting software, Tax software

Document management software

Adobe Systems Adobe Acrobat, Atrion Intelligent Authoring

Worker Requirements

Technology Skills
Data base user interface and query software
Questions20
Time Limit20 min
Skills
Active Listening
Questions20
Time Limit15 min
Knowledge
English Language
Questions20
Time Limit25 min

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.

Worker Characteristics

Technology Skills
Data base user interface and query software
Questions20
Time Limit20 min
Skills
Active Listening
Questions20
Time Limit15 min
Knowledge
English Language
Questions20
Time Limit25 min
Abilities
Written Comprehension
Questions25
Time Limit15 min
Interests
Conventional
Questions25
Time Limit20 min
Work Values
Working Conditions
Questions25
Time Limit20 min
Work Styles
Attention to Detail
Questions20
Time Limit15 min

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

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.

Independence

Occupations that satisfy this work value allow employees to work on their own and make decisions. Corresponding needs are Creativity, Responsibility and Autonomy.

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.

Call to action section illustrate

Our platform will answer your questions:

  • checkmark iconWhat are your candidate's cognitive abilities?
  • checkmark iconWhat's your candidate’s capacity to learn and grow?
  • checkmark iconHow will your candidates behave in the workplace?
  • checkmark iconWhat drives your candidates to engage in action?