Regulatory Affairs jobs in Malaysia

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As an Executive Regulatory Affairs, you will support the regulatory affairs team in ensuring the development, registration, and compliance of the company's products with relevant regulatory authorities. You will assist in navigating regulatory requirements and contribute to the timely and successful launch of new products as well as the maintenance of existing ones.

Duties and responsibilities

• Assist in the preparation, submission, and follow-up with appropriate regulatory bodies on registration applications and other regulatory documentation.
• Track the progress of submissions to ensure timely approvals.
• Support the provision of regulatory guidance and reviews in compliance-related activities.
• Assist in the documentation of product changes, design reviews, and labeling changes.
• Help analyze and review registration documents for new product registration, variations, and amendments for products such as health supplements, traditional medicines, and cosmetics.
• Assist in developing standard procedures for product registration applications.
• Participate in regular audits of regulatory activities.
• Assist in yearly auditing for licence application and renewal.
• Provide updates to the senior regulatory affairs team on the status of regulatory filings.
• Notify the team of potential difficulties in meeting timelines or quality standards for regulatory filings.
• Maintain and update the database of registration requirements, status, expiry dates, renewal deadlines, etc.
• Collaborate with cross-functional teams and support senior regulatory affairs staff in developing regulatory strategies.
• Participate in team meetings and contribute to discussions on regulatory issues and strategies.
• Familiarize with Quest 3, FOSIM, and Dagang Net systems.
• Gain experience in handling Halal Assurance System documentation and eHalal system.
• Assist in handling sample analysis, including coordination with third-party lab analysis centers.
• Perform any other duties as assigned by the supervisor or management.

Requirements and skills

• Candidate must possess at least Diploma/Advanced/Higher/Graduate Diploma in Food Technology/Nutrition/Dietetics or equivalent.
• At least 2 year(s) of working experience with related experience, familiar with MAL product registration and cosmetic registration by using Quest 3 system, product classification, BKKM label screening, KKLIU application, drug registration, and customs clearance.
• Experience in the pharmaceutical industry is preferred but not mandatory.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Basic understanding of regulatory systems and procedures.
• Strong attention to detail and organizational skills.
• Good communication skills, both written and verbal.
• Ability to work independently as well as in a team environment.
• Active presence on social media is a plus.

Your application will include the following questions:

• What's your expected monthly basic salary?
• How many years' experience do you have as a Regulatory Affairs Executive?
• How much notice are you required to give your current employer?