3 general skills or competencies (Job family competencies) for Regulatory Affairs Specialist I
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)
Documents and maintains accurate internal records based on established procedures.
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Level 2 Behaviors
(Light Experience)
Conducts inspections with management to provide and document corrective actions.
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Level 3 Behaviors
(Moderate Experience)
Maintains accurate records of training management to preserve throughout the life cycle.
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Level 4 Behaviors
(Extensive Experience)
Manages record management procedures to ensure better traceability.
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Level 5 Behaviors
(Mastery)
Creates a tracking system for record management to support continuous process improvement.
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Skill definition-Ensuring that the staff is following all policies and procedures in our business.
Level 1 Behaviors
(General Familiarity)
Documents the processes used in developing and implementing compliance monitoring plans.
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Level 2 Behaviors
(Light Experience)
Collects data and submits required reports necessary for workforce compliance and monitoring.
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Level 3 Behaviors
(Moderate Experience)
Maintains monitoring systems to ensure compliance with established regulations and policies.
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Level 4 Behaviors
(Extensive Experience)
Leads in the analysis of potential risks faced across your entire organization.
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Level 5 Behaviors
(Mastery)
Develops overall monitoring plans to identify compliance risks immediately.
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8 soft skills or competencies (core competencies) for Regulatory Affairs Specialist I
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)
Follows and respects the industry standards and regulations.
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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)
Educates others to enhance product and industry-specific knowledge across our business.
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Level 5 Behaviors
(Mastery)
Keeps apprised of industry trends and applies the expertise to business strategy.
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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)
Describes own business unit's role in the production of our organization's P/S.
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Level 2 Behaviors
(Light Experience)
Outlines the main advantages of our business's main P/S.
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Level 3 Behaviors
(Moderate Experience)
Examines the products and services from the perspective of the customer.
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Level 4 Behaviors
(Extensive Experience)
Incorporates quantifiable evidence to prove that the value of the product is credible.
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Level 5 Behaviors
(Mastery)
Educates others on the structure and integration of cross-functional products or services.
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Summary of Regulatory Affairs Specialist I skills and competencies
There are 0 hard skills for Regulatory Affairs Specialist I.
3 general skills for Regulatory Affairs Specialist I, Records Management, Compliance Monitoring, Legal Document Review.
8 soft skills for Regulatory Affairs Specialist I, 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 I, he or she needs to be proficient in Industry Knowledge, be proficient in Products And Services, and be proficient in Standard Operating Procedures (SOP).