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%
$86,206
TOTAL 50%
$90,423
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)
Explains record management standard practices and procedures.
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Level 2 Behaviors
(Light Experience)
Supports record management and data collection to comply with laws and regulations.
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Level 3 Behaviors
(Moderate Experience)
Performs data maintenance for records to reduce the liabilities associated with document disposal.
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Level 4 Behaviors
(Extensive Experience)
Organizes document and record management activities to help detect errors and prevent fraud.
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Level 5 Behaviors
(Mastery)
Develops and implements procedures to document scanning and retention in the management system.
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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)
Identifies the guiding principles of corporate compliance monitoring.
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Level 2 Behaviors
(Light Experience)
Gathers necessary information to support compliance monitoring and assessment.
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Level 3 Behaviors
(Moderate Experience)
Performs procedure analytics and monitoring to identify potential violations.
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Level 4 Behaviors
(Extensive Experience)
Oversees the overall development and implementation of the compliance monitoring plan.
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Level 5 Behaviors
(Mastery)
Improves your organization's compliance monitoring plans by staying abreast of the latest laws 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)
Lists the industry's key players and leading companies.
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Level 2 Behaviors
(Light Experience)
Identifies internal and external resources that can provide additional industry knowledge.
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Level 3 Behaviors
(Moderate Experience)
Provides industry knowledge and expertise to maximize departmental efficiency and performance.
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Level 4 Behaviors
(Extensive Experience)
Raises peers' awareness of changes in industry environment and practices.
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Level 5 Behaviors
(Mastery)
Monitors industry changes and communicates impacts to the management team.
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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 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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