Overview
Regulatory Affairs Executive Jobs in Petaling Jaya, Selangor, Malaysia at Hyphens Pharma International Ltd.
Title: Regulatory Affairs Executive
Company: Hyphens Pharma International Ltd.
Location: Petaling Jaya, Selangor, Malaysia
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 advertisement application to ensure compliance to local regulations
Work Experiences & Qualifications:
- Preferably a registered pharmacist recognized by Ministry of Health, Malaysia
- Minimum 2 year of experience in regulatory affairs
- Interested to develop skills in product registration submission, maintenance of it while ensuring continuity of supply in market
- Able to multi-tasking and embrace dynamic changes
- Able to communicate fluently in both English & Bahasa Malaysia (oral and written)
