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Full-Time Opportunity: This is a permanent, full-time position with a competitive package and real career growth potential.
Job Description
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...