Skills & Competencies for Regulatory Affairs Manager

Regulatory Affairs Manager job profile

Book a Demo and Receive a Sample Job Profile

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
BOOK A DEMO

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)
Identifies the guiding principles of corporate compliance monitoring.
See 4 More Skill Behaviors
Level 2 Behaviors
(Light Experience)
Gathers necessary information to support compliance monitoring and assessment.
See 4 More Skill Behaviors
Level 3 Behaviors
(Moderate Experience)
Performs procedure analytics and monitoring to identify potential violations.
See 4 More Skill Behaviors
Level 4 Behaviors
(Extensive Experience)
Oversees the overall development and implementation of the compliance monitoring plan.
See 4 More Skill Behaviors
Level 5 Behaviors
(Mastery)
Improves your organization's compliance monitoring plans by staying abreast of the latest laws and regulations.
See 4 More Skill Behaviors
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)
Lists the legal encyclopedias to explain law and references.
See 4 More Skill Behaviors
Level 2 Behaviors
(Light Experience)
Explains the analysis results as required by our business, management, or clients.
See 4 More Skill Behaviors
Level 3 Behaviors
(Moderate Experience)
Performs complex research and analysis of a multi-part rule for complicated legal issues.
See 4 More Skill Behaviors
Level 4 Behaviors
(Extensive Experience)
Oversees the identification of relevant facts and drafting of legal documents.
See 4 More Skill Behaviors
Level 5 Behaviors
(Mastery)
Establishes strategies to deal with the legal issue and means of delivery of the completed analysis.
See 4 More Skill Behaviors
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)
Lists the industry's key players and leading companies.
See 4 More Skill Behaviors
Level 2 Behaviors
(Light Experience)
Gathers market and customer needs to provide input for product and service solutions.
See 4 More Skill Behaviors
Level 3 Behaviors
(Moderate Experience)
Provides industry knowledge and expertise to maximize departmental efficiency and performance.
See 4 More Skill Behaviors
Level 4 Behaviors
(Extensive Experience)
Monitors the industry regulatory trends and changes to ensure compliance.
See 4 More Skill Behaviors
Level 5 Behaviors
(Mastery)
Leads the research and discussion on industry-specific issues and challenges.
See 4 More Skill Behaviors
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)
Lists the key benefits and effects of business process improvement.
See 4 More Skill Behaviors
Level 2 Behaviors
(Light Experience)
Identifies the constraints causing bottlenecks in our production.
See 4 More Skill Behaviors
Level 3 Behaviors
(Moderate Experience)
Pinpoints extraneous steps and sub-steps within the process that don't seem to serve a purpose.
See 4 More Skill Behaviors
Level 4 Behaviors
(Extensive Experience)
Monitors and evaluates the success or failure of the changes implemented.
See 4 More Skill Behaviors
Level 5 Behaviors
(Mastery)
Promotes the automation of processes to minimize the number of manual steps and errors.
See 4 More Skill Behaviors
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.

It's Easy to Get Started

Get the precision you need to assess, hire, and develop top talent with skills and competencies – see how with a personalized demo.