Oversee and manage the entire process of product registration, ensuring compliance with regulatory requirements and timely submissions local and overseas.
Plan, coordinate, and execute Regulatory Affairs (RA) activities within the designated region, ensuring alignment with company objectives and regulatory standards.
Manage the full regulatory lifecycle of products, including initial submissions, approvals, variations, renewals, and ongoing maintenance with the national regulatory authorities.
...
Be responsible for and follow the agreed plan and timelines for Registration Projects to meet client and internal stakeholder objectives
Ensure compliance, monitor, and update changes related to regulations set by local Regulatory Agencies and support the Head of Regulatory Affairs on other regulatory affairs matter when necessary
Ensure continuous knowledge update on the registration process for Pharmaceuticals, Biotech, Health Supplements, Generics, Medical Device, Veterinary and Cosmetics in Malaysia
...
Bachelor's Degree in Biomedical Science, Pharmacy, Supply Chain Management, Life Sciences, Engineering, or a related discipline
Minimum 8–10 years of leadership experience within Regulatory Affairs, Quality Assurance, Commercial Supply Chain, Medical Device, MedTech, Healthcare Distribution, or Healthcare Sourcing industries
Proven experience managing multi-country medical device registrations and regulatory submissions across ASEAN markets
...
Assist in compiling and organizing documents required for product registration/information (e.g. MoH Food & Pharma. Div., RMCD, DOSH etc).
Review and validate product labels, packaging, promotional materials, and technical documents from regulatory perspective to ensure regulatory compliance.
Help translate or format technical documents when necessary.
...
Supporting the Pharma commercial teams on topics including regulatory, legal compliance, quality and product safety.
Document preparation, handling product registration applications ensuring drugs are legally authorised for the markets intended.
Completion of technical and regulatory information requests from customers within the pharmaceutical industry (questionnaires, supply chain agreements, QAA’s & TA’s).
...