About the job
Specialist - Regulatory Affairs
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.
Top activities and tasks for this job:
- Evaluating Information to Determine Compliance with Standards
- Getting Information
- 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.
- Communicating with Supervisors, Peers, or Subordinates
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
About the test (Full Version)
The Specialist - Regulatory Affairs Pre-Employment Assessment was designed to help you hire staff in this role. The test provides a whole-person evaluation by measuring job-relevant cognitive ability, personality, knowledge, skills, and relevant behavioral history.
Each component provides important data for hiring decisions. Cognitive ability has been linked to overall job performance in most jobs and correlates with a candidate's
ability to learn new skills and to solve complex problems. Personality characteristics determine how well the candidate will fit-in with a corporate culture. Knowledge and skills indicate how much training will be needed before a new employee becomes productive. Finally, relevant behavioral history detects counter-productive behaviors that can impact job performance.
The Specialist - Regulatory Affairs test includes an animated work simulation in which candidates meet customers, colleagues and supervisors in a job-related context. Post-test surveys indicate the majority of candidates react favorably to these simulations.
This test also contains an automatically-scored essay component. Writing is a key skill for many jobs and also demonstrates the ability to generate, organize, and communicate relevant ideas effectively.
The specific attributes measured include:
Cognitive Ability
- Analytical Thinking and Attention to Detail
|
|
Knowledge and Skills
|
Personality
- Adaptability
- Drive
- Integrity
- Resilience
- Teamwork
|
|
Emotional Intelligence
- Empathy and Emotional Self-Control
|
Behavioral History
- History Survey - Performance
- History Survey - Tenure
|
|
|
Following completion, the test produces a Candidate Selection Report that includes an overall score and detailed scores for each attribute. The overall score weighs each of the factors based on research and analysis from the U.S. Government's Occupational Information Network (O*Net). O*Net represents over a decade of dedicated research evaluating the relative importance of various factors that lead to success in almost 1,000 different job roles.
The Candidate Selection Report also provides expert interview questions that help you probe critical or low-scoring areas, along with a guide for noting your evaluation of the candidate's responses. Consistent use of an interview guide is an important part of gaining better candidate insights and making better hiring decisions.
More information about this Job
Annual US Wages (2023) |
Bottom 10%: | | $43,790 or less |
Bottom 25%: | | $56,180 or less |
Median: | | $75,670 (Average) |
Top 25%: | | $100,340 or more |
Top 10%: | | $123,710 or more |
US Employment Statistics |
2023: | | 403,900 |
2033 (projected): | | 425,800 |
Annual U.S. Job Openings: | 34,400 |
Top Knowledge Requirements
- English Language
- Law and Government
- Biology
- Computers and Electronics
- Administration and Management
- Administrative
|
Top Skills
- Active Listening
- Writing
- Speaking
- Judgment and Decision Making
- Critical Thinking
- Reading Comprehension
- Complex Problem Solving
- Systems Analysis
|
Top Abilities
- Written Comprehension
- Written Expression
- Oral Expression
- Oral Comprehension
- Speech Clarity
- Inductive Reasoning
- Deductive Reasoning
- Problem Sensitivity
|
|
Education Requirements |
Bachelor's Degree: | | 80% |
Post-Baccalaureate Certificate: | | 5% |
Master's Degree: | | 10% |
Post-Doctoral Training: | | 5% |
This graphic shows the percentage of people in this role who have their highest education in each category. |
Related Work Experience Requirements |
None: | | 5% |
6 Months - 1 Year: | | 5% |
1 - 2 Years: | | 25% |
2 - 4 Years: | | 55% |
4 - 6 Years: | | 10% |
This graphic shows the percentage of people in this role whose related work experience before they entered this position falls into each category. |
Alternate Titles for this Role: Clinical Quality Assurance Associate, Clinical Quality Assurance Specialist, Drug Regulatory Affairs Specialist, Product Safety Specialist, Quality Assurance Documentation Coordinator, Quality Assurance Documentation Specialist, Regulatory Affairs Analyst (RA Analyst), Regulatory Affairs Associate (RA Associate), Regulatory Affairs Consultant (RA Consultant), Regulatory Affairs Coordinator (RA Coordinator), Regulatory Affairs Specialist (RA Specialist), Regulatory Affairs Strategist (RA Strategist), Regulatory Analyst, Regulatory Compliance Associate, Regulatory Compliance Specialist, Regulatory Engineer, Regulatory Services Consultant, Regulatory Specialist, Regulatory Submissions Associate, Research Compliance Specialist
Related Jobs based on Skills & Abilities: Regulatory Affairs Managers, Compliance Managers, Environmental Compliance Inspectors, Quality Control Systems Managers, Government Property Inspectors and Investigators, Document Management Specialists, Compliance Officers, Coroners, Equal Opportunity Representatives and Officers, Customs Brokers, Clinical Data Managers, Management Analysts, Clinical Research Coordinators, Quality Control Analysts, Environmental Scientists and Specialists, Including Health