1, Regulatory Compliance:
Checking monthly intellectual property gazette and providing advice/warning to senior management of the products;
Support in training to internal teams on regulatory matters, ensuring a company- wide understanding of compliance requirements.
Ensuring that company&039;s products comply with the local regulation;
Stay up- to- date with local, national, and international regulations and standards pertaining to pharmaceuticals, cosmetics. functional food, insect repellent and medical devices;
2, Product Registration:
Developing and writing clear arguments and explanations for product licences;
Monitoring and setting timelines liaising with, and making presentations to regulatory authorities.
Preparing submissions of licence variations and renewals to strict deadlines pertaining to pharmaceuticals, cosmetics. functional food, insect repellent and medical devices;
3, Cross- functional Collaboration
Collaborate with R&D, Manufacturing, Marketing, and other departments to align regulatory requirements with product development and commercialization goals;
Advising scientists and manufacturers on regulatory requirements;
Collaborate with relevant departments to execute the company&039;s strategic initiatives (ISO 14001, Cosmetic GMP, CE Marking Certificate, etc.)
Collecting, collating and evaluating scientific data that has been researched by colleagues;
Review and check for product labeling and packaging materials from Marketing dept. to ensure compliance with regulatory requirements;
4, Collection and management of post- market surveillance and pharmacovigilance information
Receiving, recording, and monitoring the database of all reports related to drug safety (ADRs, medication errors, suspected adverse events (AE) related to medicines, etc.) from various sources (healthcare professionals, medical examination and treatment facilities, etc.);
Preparing and submitting periodic safety update reports (PSURS) in accordance with regulations.
5, Follow other duties required from Manager.
