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)
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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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)
Locates mandatory authority and persuasive authority for legal analysis.
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Level 2 Behaviors
(Light Experience)
Participates in the discussion to identify the issues and problems raised by the clients.
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Level 3 Behaviors
(Moderate Experience)
Provides guidance on legal analytical research methods to solve the problem.
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Level 4 Behaviors
(Extensive Experience)
Recommends fair and effective outcomes to apply a well-reasoned legal analysis to the case.
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Level 5 Behaviors
(Mastery)
Stays current on legal trends to provide consultation and analysis for recommendations.
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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)
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 – 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)
Names various methods used to practice business process improvement.
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Level 2 Behaviors
(Light Experience)
Suggests changes to the existing processes and structure in our business.
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Level 3 Behaviors
(Moderate Experience)
Recommends the business process management system that meets our business needs.
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Level 4 Behaviors
(Extensive Experience)
Resolves underlying issues that bring about the business process bottlenecks.
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Level 5 Behaviors
(Mastery)
Restructures ways to align business processes with organizational goals.
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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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