Skills & Competencies for Regulatory Affairs Manager

Regulatory Affairs Manager job profile

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JOB SUMMARY for Regulatory Affairs Manager

Manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations.

JOB RESPONSIBILITIES for Regulatory Affairs Manager

Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Utilizes established monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Investigates and addresses any reported issues of non-compliance.

Regulatory Affairs Manager SALARY RANGE

BASE 50%
$146,010
TOTAL 50%
$163,013
Job Level
M02
Job Code
LE11000038
Education/Degree
Bachelor's Degree
Reports To
Director

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

1 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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2 Job Family Competencies – Legal Analysis
Proficiency Level -2
Skill definition-Developing and implementing a legal research plan to resolve various legal issues.
Level 1 Behaviors
(General Familiarity)
Describes legal analysis processes and methods, particularly in drafting appeal decisions.
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Level 2 Behaviors
(Light Experience)
Assists in developing legal analysis plans according to clients' instructions.
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Level 3 Behaviors
(Moderate Experience)
Administers legal research and analysis to complete recurring case documentation assignments.
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Level 4 Behaviors
(Extensive Experience)
Evaluates legal documentation to make recommendations based on independent analysis.
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Level 5 Behaviors
(Mastery)
Champions the adoption of advanced technology in legal research and analysis.
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3 Regulatory Affairs Manager - Skill and Competency
Proficiency Level - 3
4 Skill and Competency - Regulatory Affairs Manager
Proficiency Level - 4
5 Competency for - Regulatory Affairs Manager
Proficiency Level - 5

14 soft skills or competencies (core competencies) for Regulatory Affairs Manager

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.
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Level 2 Behaviors
(Light Experience)
Compares the operations of own department and function to the industry best practices.
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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)
Anticipates client needs using business and industry expertise to maximize competitive advantage.
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Level 5 Behaviors
(Mastery)
Contributes to industry association white papers, standards, and regulations.
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2 Core Competencies – Business Process Improvement
Proficiency Level -2
Skill definition-Proactively defining, analyzing, and streamlining existing business processes within an organization to meet new quotas or standards of quality.
Level 1 Behaviors
(General Familiarity)
Cites basic business process improvement techniques and processes.
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Level 2 Behaviors
(Light Experience)
Assists in preparing flow charts to visualize each step in the new workflow.
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Level 3 Behaviors
(Moderate Experience)
Consults in the identification and resolution of process issues.
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Level 4 Behaviors
(Extensive Experience)
Defines the best ways to align our new processes with the desired outcomes.
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Level 5 Behaviors
(Mastery)
Designs various tools to be used for the business process improvement efforts.
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3 Regulatory Affairs Manager - Skill and Competency
Proficiency Level - 3
4 Skill and Competency - Regulatory Affairs Manager
Proficiency Level - 4
5 Competency for - Regulatory Affairs Manager
Proficiency Level - 5

Summary of Regulatory Affairs Manager skills and competencies

There are 0 hard skills for Regulatory Affairs Manager.
2 general skills for Regulatory Affairs Manager, Compliance Monitoring, Legal Analysis.
14 soft skills for Regulatory Affairs Manager, Industry Knowledge, Business Process Improvement, Risk Management, etc.
While the list totals 16 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 Manager, he or she needs to be proficient in Industry Knowledge, be proficient in Business Process Improvement, and be proficient in Risk Management.

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