Assessment Template For Regulatory Affairs Managers
Regulatory Affairs Managers
Hiring success rate
89% hiring better
Test Used
18705 times
Popular Job Roles
Occupation-Specific
Technology Skills
Document management software
Tasks
- Provide responses to regulatory agencies regarding product information or issues.
- Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
- Develop regulatory strategies and implementation plans for the preparation and submission of new products.
- Manage activities such as audits, regulatory agency inspections, or product recalls.
Technology Skills
Document management software
Adlib Express, Adobe Systems Adobe Acrobat, Axway eSubmissions, Virtify eCTD
Presentation software
Microsoft PowerPoint
Compliance software
Aris Global Register, MediRegs E-dition Compliance Monitor, SAP EHS Management, Thomson Reuters Liquent InSight Suite
Data base user interface and query software
Database software, Microsoft Access, Structured query language SQL
Risk management data and analysis software
MasterControl software, Risk management software
Worker Requirements
Technology Skills
Document management software
Skills
Reading Comprehension
Knowledge
English Language
Skills
Reading Comprehension
Understanding written sentences and paragraphs in work-related documents.
Speaking
Talking to others to convey information effectively.
Writing
Communicating effectively in writing as appropriate for the needs of the audience.
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.
Coordination
Adjusting actions in relation to others' actions.
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.
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.
Biology
Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.
Medicine and Dentistry
Knowledge of the information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures.
Worker Characteristics
Technology Skills
Document management software
Skills
Reading Comprehension
Knowledge
English Language
Abilities
Written Comprehension
Interests
Enterprising
Work Values
Achievement
Work Styles
Integrity
Abilities
Written Comprehension
The ability to read and understand information and ideas presented in writing.
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.
Written Expression
The ability to communicate information and ideas in writing so others will understand.
Deductive Reasoning
The ability to apply general rules to specific problems to produce answers that make sense.
Interests
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.
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.
Work Values
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.
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
Integrity
Job requires being honest and ethical.
Attention to Detail
Job requires being careful about detail and thorough in completing work tasks.
Dependability
Job requires being reliable, responsible, and dependable, and fulfilling obligations.
Stress Tolerance
Job requires accepting criticism and dealing calmly and effectively with high-stress situations.
Leadership
Job requires a willingness to lead, take charge, and offer opinions and direction.
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