Skills & Competencies for Regulatory Affairs Specialist I

Regulatory Affairs Specialist I job profile

Book a Demo and Receive a Sample Job Profile

JOB SUMMARY for Regulatory Affairs Specialist I

Supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations.

JOB RESPONSIBILITIES for Regulatory Affairs Specialist I

Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Participates in processes to report, investigate, and addresses any issues of non-compliance.

Regulatory Affairs Specialist I SALARY RANGE

BASE 50%
$68,245
TOTAL 50%
$71,668
Job Level
P01
Job Code
RD14000084
Education/Degree
Bachelor's Degree
Reports To
Supervisor or Manager

Regulatory Affairs Specialist I Skills and Competencies List

Proficiency Levels and Behavioural Indicators
Salary.com identifies five increasing levels of proficiency for each skill/competency. Some jobs require only a relatively low level of proficiency in each skill/competency, while other jobs will require a more advanced level of proficiency in the same skill/competency. These levels rate the degree of proficiency (skill level, expertise) we expect the incumbent to perform in the given skill/competency for the given job. Note that we intentionally do not associate timeframes or years of experience in performing the skill/competency because that can be misleading. Proficiency levels identify what the incumbent knows and can do rather than how long they have been doing it. Also, note that the proficiency levels are cumulative, e.g., a level 4 proficiency implies the ability to perform all the behaviors at the lower levels.
Check each Regulatory Affairs Specialist I skill and competencie below to view definitions.
JOB FAMILY COMPETENCIES CORE COMPETENCIES
BOOK A DEMO

3 general skills or competencies (Job family competencies) for Regulatory Affairs Specialist I

1 Job Family Competencies – Records Management
Proficiency Level -1
Skill definition-Managing and preserving records to help an organization keep the documentation accessible for both business operations and compliance audits.
Level 1 Behaviors
(General Familiarity)
Compiles a list of issues and concerns for secured and accurate record keeping.
See 4 More Skill Behaviors
Level 2 Behaviors
(Light Experience)
Collects data to prepare management reports of production results.
See 4 More Skill Behaviors
Level 3 Behaviors
(Moderate Experience)
Handles record management assessments to identify any areas for improvement.
See 4 More Skill Behaviors
Level 4 Behaviors
(Extensive Experience)
Audits recordkeeping entries to track and monitor implementation and sustainment progress.
See 4 More Skill Behaviors
Level 5 Behaviors
(Mastery)
Adapts your organization with new approaches to improve records and information management.
See 4 More Skill Behaviors
2 Job Family Competencies – Compliance Monitoring
Proficiency Level -2
Skill definition-Ensuring that the staff is following all policies and procedures in our business.
Level 1 Behaviors
(General Familiarity)
Compiles a list of compliance monitoring challenges, gaps, and regulatory needs.
See 4 More Skill Behaviors
Level 2 Behaviors
(Light Experience)
Assists in reviewing documentation to ensure compliance with program and federal guidelines.
See 4 More Skill Behaviors
Level 3 Behaviors
(Moderate Experience)
Administers testing programs to ensure compliance with all applicable laws and regulations.
See 4 More Skill Behaviors
Level 4 Behaviors
(Extensive Experience)
Creates compliance monitoring dashboards to identify and resolve compliance issues on time.
See 4 More Skill Behaviors
Level 5 Behaviors
(Mastery)
Creates overall monitoring strategies to mitigate compliance and operational risks.
See 4 More Skill Behaviors
3 Regulatory Affairs Specialist I - Skill and Competency
Proficiency Level - 3
4 Skill and Competency - Regulatory Affairs Specialist I
Proficiency Level - 4
5 Competency for - Regulatory Affairs Specialist I
Proficiency Level - 5

8 soft skills or competencies (core competencies) for Regulatory Affairs Specialist I

1 Core Competencies – Industry Knowledge
Proficiency Level -2
Skill definition-Demonstrating thorough knowledge of the industry's value chain, business, issues, trends, etc., and the ability to apply them appropriately.
Level 1 Behaviors
(General Familiarity)
Cites critical statistics regarding the industry's size and influence.
See 4 More Skill Behaviors
Level 2 Behaviors
(Light Experience)
Compares the operations of own department and function to the industry best practices.
See 4 More Skill Behaviors
Level 3 Behaviors
(Moderate Experience)
Communicates industry and market trends affecting business operations to internal stakeholders.
See 4 More Skill Behaviors
Level 4 Behaviors
(Extensive Experience)
Anticipates client needs using business and industry expertise to maximize competitive advantage.
See 4 More Skill Behaviors
Level 5 Behaviors
(Mastery)
Contributes to industry association white papers, standards, and regulations.
See 4 More Skill Behaviors
2 Core Competencies – Products And Services
Proficiency Level -1
Skill definition-Knowledge of the full array of our organization's products and services including those that are created for internal customers; insight into the differentiating factors that distinguish them from those of competitors.
Level 1 Behaviors
(General Familiarity)
Cites examples of how customers use our business's products and services.
See 4 More Skill Behaviors
Level 2 Behaviors
(Light Experience)
Describes our organization's current marketing campaign.
See 4 More Skill Behaviors
Level 3 Behaviors
(Moderate Experience)
Announces and explains updates of products and services and delivery.
See 4 More Skill Behaviors
Level 4 Behaviors
(Extensive Experience)
Enhances employees' understanding of several sets of interrelated products and services and their interdependence.
See 4 More Skill Behaviors
Level 5 Behaviors
(Mastery)
Conceives and plans our business’s future structure according to the target market and P/S strategy.
See 4 More Skill Behaviors
3 Regulatory Affairs Specialist I - Skill and Competency
Proficiency Level - 3
4 Skill and Competency - Regulatory Affairs Specialist I
Proficiency Level - 4
5 Competency for - Regulatory Affairs Specialist I
Proficiency Level - 5

Summary of Regulatory Affairs Specialist I skills and competencies

There are 0 hard skills for Regulatory Affairs Specialist I.
3 general skills for Regulatory Affairs Specialist I, Records Management, Compliance Monitoring, Legal Document Review.
8 soft skills for Regulatory Affairs Specialist I, Industry Knowledge, Products And Services, Standard Operating Procedures (SOP), etc.
While the list totals 11 distinct skills, it's important to note that not all are required to be mastered to the same degree. Some skills may only need a basic understanding, whereas others demand a higher level of expertise.
For instance, as a Regulatory Affairs Specialist I, he or she needs to be proficient in Industry Knowledge, be proficient in Products And Services, and be proficient in Standard Operating Procedures (SOP).

It's Easy to Get Started

Get the precision you need to assess, hire, and develop top talent with skills and competencies – see how with a personalized demo.