Regulatory Affair Executive

Public Medicare Group; Kuala Lumpur; On-site; MYR 30,000 - 40,000; Full time

Job summary

A healthcare organization in Kuala Lumpur is seeking a Regulatory Affairs Assistant to assist with product registration, ensure compliance with regulations, and maintain documentation. The ideal candidate holds a Bachelor’s degree in a relevant field and has entry-level experience in regulatory affairs. This position offers an opportunity to work collaboratively across departments to support regulatory compliance efforts and manage documentation effectively.

Qualifications

• Bachelor's degree in a relevant field.
• Entry level experience in regulatory affairs is a plus.

Responsibilities

• Prepare documents for product registration and approvals.
• Monitor regulatory changes and ensure compliance.
• Organize and maintain regulatory files and databases.

Skills

Regulatory compliance

Documentation management

Communication

Education

Bachelor Degree in Food, Food Technology, Life Science, Pharmacy or Chemistry

Job description

Assist in the preparation, reviewal and submission of the document for product registration, renewal and various application.

Maintain accurate and up to date records for all regulatory submission and approval.

Compile the dossiers in accordance with the regulatory guideline and company procedure.

Compliance

Monitor and track regulatory changes and update in relevant markets and communicate the information to the teammate.

Ensure products compliance toward all local, regional and international regulations.

Assist in the review of product labels, packaging and promotional materials for regulatory compliances purposes.

Work closely with the internal teammate (R&D Teammate, Quality Assurance Teammate and Marketing Teammate) to ensure the compliance accoss all departments.

Support the regulatory team in responding to queries from regulatoty bodies.

Documentation Management

Organize and maintain regulatory files and databases ensure all documents are update and accessible.

Prepare the regulatory reports and summaries for management review

Education and Experience

Bachelor Degree in Food, Food Technology, Life Science, Pharmacy or Chemistry - or any related field.

Entry level experience in regulatory affair - or any related field is an added advantage.