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
...
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).
...