Regulatory Affairs Senior Executive / Assistant Manager

LUXASIA; Kuala Lumpur; On-site; MYR 36,000 - 60,000; Full time

Job summary

A leading company in the cosmetics industry is seeking a Regulatory Data Manager in Kuala Lumpur. The role involves ensuring compliance through data management and regulatory submissions. Ideal candidates will have a background in Information Management with 3-6 years of relevant experience, possessing strong communication skills and familiarity with regulatory environments.

Qualifications

• Minimum 3-6 years working experience in regulatory fields.
• Candidates with internship experience in regulatory data management roles in pharmaceuticals can apply.

Responsibilities

• Coordinate large scale regulatory data management to centralized cloud platforms.
• Conduct Regulatory Data Compliance Audits.
• Manage data extraction processes with provided tools.

Skills

Strong communication skills

Data management principles

Regulatory Data management

Education

B.Sc Information Management

Tools

Regulatory Data management software

Job description

To ensure regulatory compliance for cosmetics by managing E-notification processes with NPRA, reviewing product dossiers and artworks, and coordinating registration renewals and compliance checks. This role is essential for import clearance, maintaining the product registration database, and ensuring adherence to labelling guidelines.

Main Roles and Responsibilities:

• Coordinate large scale regulatory data management to assigned centralized cloud platforms
• Conduct Regulatory Data Compliance Audits to govern integrity of data
• Collect, organize and maintain data for regulatory submissions
• Stay updated with Country /Brand Regulatory Leads and coordinate data requests
• Lead change management processes regionally
• Manage data extraction processes with tools provided
• Prepare reports summarizing regulatory notification status

Added Advantage

• Able to use end to end Regulatory Data management softwares
• Proficiency in data management principles and best practices

• B.Sc Information Management

• Familiarity with data management software and databases

• Strong communication skills, excellent spoken and written English
• Any working experience in regulatory fields at the following industries welcomed, cosmetics, food and Pharmaceutical
• Minimum 3-6 years working experience. Candidates who have internship experience in regulatory data management roles in pharmaceutical industries may also apply.