Regulatory Affairs

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Related Professions

What is Regulatory Affairs?

Regulatory affairs, also called government affairs, plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures. Regulatory affairs also responsible in communicating regulatory information to multiple departments and ensure that information is interpreted correctly.

Minimum education level

PT3

SPM

STPM

Diploma

Degree

Average Salary

RM2836 - RM 5836

Example of a Job Position

Clinical Trials Systems Administrator

Global Regulatory Affairs Manager

Regulatory Affairs Director

Regulatory Affairs Manager

Regulatory Affairs Portfolio Leader

Regulatory Consultant

Regulatory Leader

Regulatory Product Manager

Task

? Direct the preparation and submission of regulatory agency applications, reports, or correspondence ? Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards ? Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products ? Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced

Knowledge

Administrative

Knowledge of administrative procedures and systems, such as managing words, managing documents and records, stenography and transcription, designing forms, and other office procedures and terminology.

Administration and Management

Knowledge of business and management principles including strategic planning, resource allocation, human resource modeling, leadership techniques, production methods, and coordination between people and resources.

English

Knowledge of the structure and content of English, including the meaning and spelling of each word, composition rules, and grammar.

Law and Governance

Knowledge of laws, legal rules, court procedures, precedents, government regulations, executive orders, institutional rules, and democratic political processes.

Skills

Talking

Talk to others to convey information effectively

Writing

Communicate effectively through writing that suits the needs of the audience

Complex Problem Solving

Identify complex problems and review related information in order to develop and evaluate options and solutions that can be applied.

Critical Thinking

Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to the problems handled

Reading Understanding

Understand sentences and paragraphs written in work documents.

Coordination

Adjust the actions taken, with the actions of others.

Capability

1
Information Ordering - The ability to arrange things or actions in a certain order or pattern according to a specific rule or set of rules (e.g., patterns of numbers, letters, words, pictures, mathematical operations).
2
Written Comprehension - The ability to read and understand information and ideas presented in writing