Manage end-to-end regulatory submissions — including pre-market and post-market regulatory activities such as product registration, license renewals, import permits, special authorizations, product recalls, and lifecycle updates in full compliance with applicable regulations for Medical Devices and Pharmaceutical Products.
Ensure oversight on key processes and ensure framework is in place to manage third-party activities E2E ensuring compliance with regulations and company standards; monitor partner performance against agreed-upon metrics and standards, addressing any deviations or deficiencies promptly
Prepare, compile and review regulatory dossiers for product registration applications in international markets, including CTD, ACTD and other applicable formats.
Deliver regulatory strategies and submissions across complementary medicines, registered medicines, medical devices, foods, cosmetics and FMCG products.
Main liaison personnel with Head Quarters and all Partners on Regulatory matters for APAC HQ's countries, not limited to Singapore, Malaysia, Indonesia, Philippines, Thailand, Vietnam, Australia & New Zealand.
Develop AI Training Content: Create detailed prompts and gold-standard compliance outputs (policies, control descriptions, monitoring plans, risk assessments, regulatory summaries).
Develop AI Training Content: Create detailed prompts and gold-standard compliance outputs (policies, control descriptions, monitoring plans, risk assessments, regulatory summaries).
Serve as the primary liaison with government agencies and regulatory bodies such as KKM, MCMC, KKOM, SIRIM, JAKIM, KPDN and other industry authorities.
Drive the development and implementation of key remediation initiatives across Compliance and supporting Binance’s Global Money Laundering Reporting Officer (GMLRO) office
Developing and implementing compliance programs, policies, and procedures to ensure compliance with relevant laws, regulations, and industry standards.
Review & approve promotional materials and external communications (HCPs, customers, consumers) for regulatory and medical compliance with local requirements and applicable industry codes
Generation and maintenance of Technical Files/Technical Documentations and regulatory submissions to U.S. FDA, EU-NB, Health Canada under supervision. Responsible for ensuring the files are in compliance with relevant regulations and standards.
Direct experience authoring or reviewing clinical study reports, protocol synopses, or regulatory dossier modules for a pharmaceutical, biotech, or CRO organization
Assist in monitoring and reviewing the digital bank's adherence to local regulatory requirements, including those set by Bank Negara Malaysia (BNM), the Securities Commission, and other relevant bodies.
Prepare, review and coordinate local regulatory submissions (HSA, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
Manage pre-market and post-market regulatory activities, including product registration, licence renewals, import permits, special authorisations, product recalls, and lifecycle updates.