Skills & Competencies for Regulatory Affairs Specialist III

Regulatory Affairs Specialist III job profile

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JOB SUMMARY for Regulatory Affairs Specialist III

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

JOB RESPONSIBILITIES for Regulatory Affairs Specialist III

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 III SALARY RANGE

BASE 50%
$100,889
TOTAL 50%
$107,435
Job Level
P03
Job Code
RD14000086
Education/Degree
Bachelor's Degree
Reports To
Supervisor or Manager

Regulatory Affairs Specialist III 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 III 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 III

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)
Describes the functionality of record requests and escalations via management tools.
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Level 2 Behaviors
(Light Experience)
Compiles routine management reports and records to secure appropriate repositories.
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Level 3 Behaviors
(Moderate Experience)
Implements complete and accurate property records to simplify all activities and processes.
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Level 4 Behaviors
(Extensive Experience)
Integrates program management to improve the efficiency of record management.
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Level 5 Behaviors
(Mastery)
Conceptualizes strategic plans for records and practices to streamline communication and workflow.
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2 Job Family Competencies – Compliance Monitoring
Proficiency Level -3
Skill definition-Ensuring that the staff is following all policies and procedures in our business.
Level 1 Behaviors
(General Familiarity)
Describes the importance of effective compliance monitoring for the business.
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Level 2 Behaviors
(Light Experience)
Assists in the management of auditing and monitoring programs to address high-risk compliance areas.
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Level 3 Behaviors
(Moderate Experience)
Conducts periodic reviews and monitoring of implemented processes to ensure continued compliance.
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Level 4 Behaviors
(Extensive Experience)
Establishes overall metrics to evaluate the accuracy of compliance reporting.
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Level 5 Behaviors
(Mastery)
Designs monitoring systems to accomplish business objectives and regulatory compliance.
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3 Regulatory Affairs Specialist III - Skill and Competency
Proficiency Level - 3
4 Skill and Competency - Regulatory Affairs Specialist III
Proficiency Level - 4
5 Competency for - Regulatory Affairs Specialist III
Proficiency Level - 5

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

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)
Describes the entire value chain of the industry.
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Level 2 Behaviors
(Light Experience)
Follows and respects the industry standards and regulations.
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Level 3 Behaviors
(Moderate Experience)
Gathers and analyses market intelligence to drive operational optimization.
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Level 4 Behaviors
(Extensive Experience)
Educates others to enhance product and industry-specific knowledge across our business.
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Level 5 Behaviors
(Mastery)
Keeps apprised of industry trends and applies the expertise to business strategy.
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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)
Collects and summarizes information and marketing materials for R&D purposes.
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Level 2 Behaviors
(Light Experience)
Discusses the potential profitability of a proposed new product.
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Level 3 Behaviors
(Moderate Experience)
Evaluates our business’s P/S costs and prices, and market positioning.
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Level 4 Behaviors
(Extensive Experience)
Establishes related procedures for product design, development and delivery time limits.
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Level 5 Behaviors
(Mastery)
Describes the planned launch of superior products and services to stakeholders to promote enthusiasm and support.
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3 Regulatory Affairs Specialist III - Skill and Competency
Proficiency Level - 3
4 Skill and Competency - Regulatory Affairs Specialist III
Proficiency Level - 4
5 Competency for - Regulatory Affairs Specialist III
Proficiency Level - 5

Summary of Regulatory Affairs Specialist III skills and competencies

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

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