Regulatory Affairs Executive

Job Scope & Responsibilities of Regulatory Affairs Executive

• Support local regulatory work, including new product/devices/cosmetic products registration, variations and renewals
• Co-ordination of regulatory related submission/correspondence with respective local health authorities (including National Pharmaceutical Regulatory Agency, NPRA, Pharmacy Enforcement Divison and Medical Device Authority, MDA)
• Maintenance of regulatory related database and licences such as product technical files maintenance, product complaint & adverse drug reactions (ADRs) records, import and poison A licences, etc
• Support local Pharmacovigilance (PV) system in reference to local regulatory requirements and SDEA with product principals
• Assist with maintenance and preparation of local quality management system (SOPs) and internal audit in compliance to local regulatory requirements
• Reviewing marketing materials and assist with advertisemen...