Skills & Competencies for Regulatory Affairs Specialist IV

Regulatory Affairs Specialist IV job profile

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JOB SUMMARY for Regulatory Affairs Specialist IV

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

JOB RESPONSIBILITIES for Regulatory Affairs Specialist IV

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 IV SALARY RANGE

BASE 50%
$124,129
TOTAL 50%
$136,967
Job Level
P04
Job Code
RD14000109
Education/Degree
Bachelor's Degree
Reports To
Supervisor or Manager

Regulatory Affairs Specialist IV 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 IV skill and competencie below to view definitions.
JOB FAMILY COMPETENCIES CORE COMPETENCIES
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3 general skills or competencies (Job family competencies) for Regulatory Affairs Specialist IV

1 Job Family Competencies – Records Management
Proficiency Level -3
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.
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Level 2 Behaviors
(Light Experience)
Collects data to prepare management reports of production results.
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Level 3 Behaviors
(Moderate Experience)
Handles record management assessments to identify any areas for improvement.
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Level 4 Behaviors
(Extensive Experience)
Directs preparation of records to achieve proper documentation of policies and transactions.
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Level 5 Behaviors
(Mastery)
Builds administrative plans and strategies to maintain consistency in record management.
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2 Job Family Competencies – Compliance Monitoring
Proficiency Level -4
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.
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Level 2 Behaviors
(Light Experience)
Assists in reviewing documentation to ensure compliance with program and federal guidelines.
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Level 3 Behaviors
(Moderate Experience)
Administers testing programs to ensure compliance with all applicable laws and regulations.
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Level 4 Behaviors
(Extensive Experience)
Creates compliance monitoring dashboards to identify and resolve compliance issues on time.
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Level 5 Behaviors
(Mastery)
Creates overall monitoring strategies to mitigate compliance and operational risks.
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3 Regulatory Affairs Specialist IV - Skill and Competency
Proficiency Level - 3
4 Skill and Competency - Regulatory Affairs Specialist IV
Proficiency Level - 4
5 Competency for - Regulatory Affairs Specialist IV
Proficiency Level - 5

9 soft skills or competencies (core competencies) for Regulatory Affairs Specialist IV

1 Core Competencies – Industry Knowledge
Proficiency Level -3
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.
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Level 2 Behaviors
(Light Experience)
Documents industry and domain knowledge in appropriate documentation systems.
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Level 3 Behaviors
(Moderate Experience)
Communicates industry and market trends affecting business operations to internal stakeholders.
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Level 4 Behaviors
(Extensive Experience)
Demonstrates intimate knowledge of industry and market trends to provide business insights.
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Level 5 Behaviors
(Mastery)
Establishes organizational policies and processes to seek out and understand industry dynamics.
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2 Core Competencies – Products And Services
Proficiency Level -2
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.
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Level 2 Behaviors
(Light Experience)
Describes our organization's current marketing campaign.
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Level 3 Behaviors
(Moderate Experience)
Announces and explains updates of products and services and delivery.
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Level 4 Behaviors
(Extensive Experience)
Enhances employees' understanding of several sets of interrelated products and services and their interdependence.
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Level 5 Behaviors
(Mastery)
Conceives and plans our business’s future structure according to the target market and P/S strategy.
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3 Regulatory Affairs Specialist IV - Skill and Competency
Proficiency Level - 3
4 Skill and Competency - Regulatory Affairs Specialist IV
Proficiency Level - 4
5 Competency for - Regulatory Affairs Specialist IV
Proficiency Level - 5

Summary of Regulatory Affairs Specialist IV skills and competencies

There are 0 hard skills for Regulatory Affairs Specialist IV.
3 general skills for Regulatory Affairs Specialist IV, Records Management, Compliance Monitoring, Legal Document Review.
9 soft skills for Regulatory Affairs Specialist IV, Industry Knowledge, Products And Services, Standard Operating Procedures (SOP), etc.
While the list totals 12 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 IV, he or she needs to be skilled in Industry Knowledge, be proficient in Products And Services, and be skilled in Standard Operating Procedures (SOP).

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