Regulatory Affairs Executive
2 weeks ago
Responsibilities:
- Assist in Registration Matters
i.) Organising and producing product dossiers for regulatory submission for designated countries.
ii.) Liaising with regulatory authorities and distributor/agents/suppliers for regulatory matters, registration issues, documents required and progress.
iii.) Managing the process from dossier submission to approval and amendments of dossiers.
iv.) Renewing marketing authorisations and maintaining them.
v.) Applications of relevant license and certificates.
vi.) Responsible for finished artwork checking (if required).
- Assist in Checking Regulatory Requirements
- Assist in Checking Scientific Information
- Assist in Pharmacovigilance Matter
(b) Execute on pharmacovigilance activity if applicable.
- Providing Clerical and Administrative Support if needed
Requirements:
- Possess a scientific degree in Science, Pharmacy or equivalent, preferably with 13 years of regulatory affairs experience in pharmaceutical industry.
- Good written and communications skills in both English and Bahasa Melayu.
- Understanding and appreciation of relevant legal, scientific and manufacturing area.
- Discipline, detail oriented and able to work independently or part of a team.
Job Types:
Full-time, Permanent
Benefits:
- Dental insurance
- Free parking
- Health insurance
- Professional development
Schedule:
- Monday to Friday
Ability to commute/relocate:
- Ipoh: Reliably commute or planning to relocate before starting work (preferred)
Education:
- Bachelor's (preferred)
Experience:
Regulatory Affairs: 1 year (preferred)
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