Skills & Competencies for Regulatory Affairs Director

Regulatory Affairs Director job profile

JOB SUMMARY for Regulatory Affairs Director

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

JOB RESPONSIBILITIES for Regulatory Affairs Director

Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Establishes 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 Director SALARY RANGE

BASE 50%
$213,981
TOTAL 50%
$259,770
Job Level
M04
Job Code
EX05000360
Education/Degree
Bachelor's Degree
Reports To
Top Management

Regulatory Affairs Director 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 Director skill and competencie below to view definitions.

2 general skills or competencies (Job family competencies) for Regulatory Affairs Director

1 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)
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 Director - Skill and Competency
Proficiency Level - 3
4 Skill and Competency - Regulatory Affairs Director
Proficiency Level - 4
5 Competency for - Regulatory Affairs Director
Proficiency Level - 5

12 soft skills or competencies (core competencies) for Regulatory Affairs Director

1 Core Competencies – Business Acumen
Proficiency Level -3
Skill definition-Insight into our organization's business, goals, and values. Ability to design and implement initiatives that facilitate successful outcomes.
Level 1 Behaviors
(General Familiarity)
Describes how our business makes money and our key business objectives.
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Level 2 Behaviors
(Light Experience)
Assists in designing business models and operating plans.
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Level 3 Behaviors
(Moderate Experience)
Applies technical expertise, business sense, and product knowledge to manage the product lifecycle effectively.
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Level 4 Behaviors
(Extensive Experience)
Coordinates technical and business teams to solve complex and diverse customer problems.
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Level 5 Behaviors
(Mastery)
Builds strong business partnerships internally and externally to drive "win-win" business successes.
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2 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)
Cites critical statistics regarding the industry's size and influence.
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Level 2 Behaviors
(Light Experience)
Documents industry and domain knowledge in appropriate documentation systems.
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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)
Demonstrates intimate knowledge of industry and market trends to provide business insights.
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Level 5 Behaviors
(Mastery)
Establishes organizational policies and processes to seek out and understand industry dynamics.
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3 Regulatory Affairs Director - Skill and Competency
Proficiency Level - 3
4 Skill and Competency - Regulatory Affairs Director
Proficiency Level - 4
5 Competency for - Regulatory Affairs Director
Proficiency Level - 5

Summary of Regulatory Affairs Director skills and competencies

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

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