Job Responsibilities:- Assist in Registration Matters
(a) Obtaining and maintaining marketing authorizations for all categories of products regulated by drug regulatory authorities worldwide.
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
(a) Assisting to check on regulatory requirements update and determine on the need to update relevant departments within the company.
- Assist in Checking Scientific Information
(a) Assist to conduct search, obtaining and providing scientific information when needed.
- Assist in Pharmacovigilance Matter
(a) Assist to check on pharmacovigilance requirements.
(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 1-3 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.
- Note: Only shortlisted candidate will be notified.
Job Types: Full-time, Permanent
Benefits:
Free parking Professional development
Schedule:
Ability to commute/relocate:
- Ipoh: Reliably commute or planning to relocate before starting work (Preferred)
Education:
Experience:
* Regulatory Affairs: 1 year (Preferred)
