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%
$145,636
TOTAL 50%
$162,597
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)
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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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)
Identifies the legal analysis processes and methods.
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Level 2 Behaviors
(Light Experience)
Documents leading cases on the legal issue through legal research.
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Level 3 Behaviors
(Moderate Experience)
Consults on a combination of various legal and factual information.
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Level 4 Behaviors
(Extensive Experience)
Oversees the execution of complicated analysis for complex legal issues.
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Level 5 Behaviors
(Mastery)
Develops standard operating procedures to standardize legal analysis and research process.
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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)
Explains the industry's essential products and services.
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Level 2 Behaviors
(Light Experience)
Gathers market and customer needs to provide input for product and service solutions.
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Level 3 Behaviors
(Moderate Experience)
Implements and troubleshoots the industry-specific technical tools and systems.
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Level 4 Behaviors
(Extensive Experience)
Monitors the industry regulatory trends and changes to ensure compliance.
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Level 5 Behaviors
(Mastery)
Leads the research and discussion on industry-specific issues and challenges.
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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)
Explains common symptoms of inefficient processes that call for business process improvement.
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Level 2 Behaviors
(Light Experience)
Collects feedback directly from staff involved in the new process mapping.
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Level 3 Behaviors
(Moderate Experience)
Manages process improvements to ensure that the entire system works efficiently.
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Level 4 Behaviors
(Extensive Experience)
Monitors and evaluates the success or failure of the changes implemented.
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Level 5 Behaviors
(Mastery)
Leads the reorganization of the workforce based on the agreed and desired outcomes.
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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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