- Drug product registration/ product variation applications.

 - Follow up amendments related to MA license variation

 - Monitor routinely pharmaceutical regulation and policy changes and assess

   impact for timely implementation and notice of other stakeholders

 - Maintain / manage registration files and RA databases in shared drive of RA.

 - Proof reading product package label against approved label and the labeling

   regulatory requirement.

 - Communication with regulatory authorities and company headquarters.

 - Submission of drug reimbursement application to HIRA or MoWH.

 - Support drug reimbursement project.

 - Promotional material (e.g., product brochure) review against regulations and

   product approved label.

 - If required, answer/fulfill requests / queries originating from local

  authorities(MFDS, MOHW, KPIS, and HIRA etc.)

Pharmacovigilance

 - Handling of drug safety related information and report it to HQ and local

   authority –Serious adverse events from studies and spontaneous adverse

   events occurred from products

 - Report monthly reconciliation with MIS & Quality complaints

 - Provide PV training to relevant stakeholders

 - Fulfill the required tasks according to local & global procedure and regulations.

 - Management of local PV SOPs

 - Ensure a scientific and regulatory intelligence related to Pharmacovigilance.

 - Learn HQ PV system & procedures and assess/ implement it to local SOPs &

   procedures.

- Fulfill MFDS PV inspection

 - To be registered to MFDS as PV responsible pharmacist.

 - Qualification of pharmacist in Bachelor or Higher degree.

 - 3-7 years’ experience in RA and/or PV in pharmaceutical company

 - Proficient in MS Office, including Word, Excel and PowerPoint

 - Effective communication and interpersonal skills

 - Good verbal and writing English skill is preferred

 - Knowledge of pharmaceutical regulations