Skills & Competencies for Regulatory Affairs Specialist II

Regulatory Affairs Specialist II job profile

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JOB SUMMARY for Regulatory Affairs Specialist II

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

JOB RESPONSIBILITIES for Regulatory Affairs Specialist II

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 II SALARY RANGE

BASE 50%
$84,542
TOTAL 50%
$88,703
Job Level
P02
Job Code
RD14000085
Education/Degree
Bachelor's Degree
Reports To
Supervisor or Manager

Regulatory Affairs Specialist II 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 II 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 II

1 Job Family Competencies – Records Management
Proficiency Level -2
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)
Lists security incident data into a record management system to ensure integrity.
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Level 2 Behaviors
(Light Experience)
Tracks inquiries using record management database-related problem documentation.
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Level 3 Behaviors
(Moderate Experience)
Utilizes document and data management systems to monitor and record all aspects of client casework.
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Level 4 Behaviors
(Extensive Experience)
Oversees the management of records to ensure confidentiality and security.
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Level 5 Behaviors
(Mastery)
Establishes procedures to facilitate a sustainable record management process.
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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)
Lists the basic functions and features of the compliance monitoring system.
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Level 2 Behaviors
(Light Experience)
Supports the auditing and monitoring of business activities to ensure compliance with regulations.
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Level 3 Behaviors
(Moderate Experience)
Utilizes advanced tools to monitor potential compliance risks and adherence to the company policy.
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Level 4 Behaviors
(Extensive Experience)
Recommends improvement opportunities for compliance monitoring to achieve the objectives.
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Level 5 Behaviors
(Mastery)
Promotes the use of a compliance monitoring system to maintain adherence to rules and regulations.
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3 Regulatory Affairs Specialist II - Skill and Competency
Proficiency Level - 3
4 Skill and Competency - Regulatory Affairs Specialist II
Proficiency Level - 4
5 Competency for - Regulatory Affairs Specialist II
Proficiency Level - 5

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

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)
Names the primary regulatory agencies of the industry.
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Level 2 Behaviors
(Light Experience)
Incorporates industry knowledge and product expertise to conduct one's work.
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Level 3 Behaviors
(Moderate Experience)
Updates our organizational knowledge database to reflect the latest industry developments.
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Level 4 Behaviors
(Extensive Experience)
Serves as an industry expert with deep domain knowledge to solve critical operational issues.
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Level 5 Behaviors
(Mastery)
Predicts the evolution of industry regulations and potential implications to our business.
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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)
Illustrates how customers use our business's products and services.
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Level 2 Behaviors
(Light Experience)
Uses precise and appropriate terminology to explain the characteristics of the P/S.
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Level 3 Behaviors
(Moderate Experience)
Obtains information regarding the commonalities of diverse products and services within our business.
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Level 4 Behaviors
(Extensive Experience)
Proposes solutions to colleagues regarding implementation and operation-related considerations.
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Level 5 Behaviors
(Mastery)
Provides a full range of consulting for the product and service production team.
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3 Regulatory Affairs Specialist II - Skill and Competency
Proficiency Level - 3
4 Skill and Competency - Regulatory Affairs Specialist II
Proficiency Level - 4
5 Competency for - Regulatory Affairs Specialist II
Proficiency Level - 5

Summary of Regulatory Affairs Specialist II skills and competencies

There are 0 hard skills for Regulatory Affairs Specialist II.
3 general skills for Regulatory Affairs Specialist II, Records Management, Compliance Monitoring, Legal Document Review.
8 soft skills for Regulatory Affairs Specialist II, 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 II, he or she needs to be proficient in Industry Knowledge, be proficient in Products And Services, and be proficient in Standard Operating Procedures (SOP).

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