Technical & Regulatory Assistant Manager

Location: Bandar Sunway, Petaling Jaya

Job Descriptions:

• Support Product Development & Regulatory Submissions Collaborate with RA, R&D, and global teams to review formulations, support product claims, and provide technical input for regulatory documentation during product development.
• Ensure Regulatory Compliance Stay updated on relevant regulations and standards, interpret guidelines, recommend procedural changes, and coordinate with labs for required sample submissions.
• Regulatory Compliance & Documentation Ensure compliance with local, regional, and corporate regulatory requirements for product registration, licensing, audits, post-market surveillance, and documentation. Maintain accurate records and registration files.
• Regulatory Submissions & Approvals Coordinate timely product submissions, variations (e.g., production transfer, second source), and obtain necessary permits and licenses by working with global teams and local authorities.
• Stakeholder & Agency Communication Collaborate with International RA Director, QA, and marketing teams; communicate with regulatory agencies to manage inquiries, clarify requirements, and support advertising material submissions (e.g., KKLIU, MDTCA).
• Industry & Regulatory Engagement Actively engage with trade associations (e.g., DSAM, MADSA, CTFAM) and regulatory authorities to strengthen relationships, monitor regulatory developments, support product approvals, and respond to government or industry requests.
• Consumer Advocacy & Complaint Resolution Act as the voice of the consumer by addressing and resolving product quality complaints, analyzing issues, and coordinating recalls or market withdrawals when needed.
• Quality Compliance & Documentation Oversee quality checks, ensure product specifications and related documents are up-to-date and compliant, and maintain QA Standard Operating Procedures for continuous improvement.

Job Requirements:

• Bachelor’s Degree in Pharmacy, Science or relevant field.
• 4 to 5 years of experience in a technical or regulatory discipline, particularly in health supplements, traditional medicine, and cosmetics
• Knowledge of and experience with local regulations, particularly in product registration processes.
• Strong analytical abilities with attention to detail, effective problem-solving, and decision-making skills for operational issues.
• Demonstrates strong integrity.
• Excellent interpersonal, presentation, and communication skills, both written and verbal.
• Self-motivated and able to independently manage and prioritize workload.
• Proficient in spoken and written English and Bahasa.

Others Information:

For those who have what it takes, please send in resume to:
Consultant in Charge: Wei Li
Email: weili@brightprospect.com.my