3 general skills or competencies (Job family competencies) for Regulatory Affairs Specialist II
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)
Compiles a list of issues and concerns for secured and accurate record keeping.
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Level 2 Behaviors
(Light Experience)
Collects data to prepare management reports of production results.
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Level 3 Behaviors
(Moderate Experience)
Handles record management assessments to identify any areas for improvement.
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Level 4 Behaviors
(Extensive Experience)
Audits recordkeeping entries to track and monitor implementation and sustainment progress.
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Level 5 Behaviors
(Mastery)
Adapts your organization with new approaches to improve records and information management.
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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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8 soft skills or competencies (core competencies) for Regulatory Affairs Specialist II
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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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)
Cites examples of how customers use our business's products and services.
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Level 2 Behaviors
(Light Experience)
Describes our organization's current marketing campaign.
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Level 3 Behaviors
(Moderate Experience)
Announces and explains updates of products and services and delivery.
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Level 4 Behaviors
(Extensive Experience)
Enhances employees' understanding of several sets of interrelated products and services and their interdependence.
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Level 5 Behaviors
(Mastery)
Conceives and plans our business’s future structure according to the target market and P/S strategy.
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Summary of Regulatory Affairs Specialist II skills and competencies
There are 0 hard skills for Regulatory Affairs Specialist II.
3 general skills for Regulatory Affairs Specialist II, Records Management, Compliance Monitoring, Legal Document Review.
8 soft skills for Regulatory Affairs Specialist II, 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 II, he or she needs to be proficient in Industry Knowledge, be proficient in Products And Services, and be proficient in Standard Operating Procedures (SOP).