Executive (RA,PV,MI,QM)

JOB DESCRIPTION:

To perform regulatory affairs related matters including preparation, submission, follow up
effectively and timely manner new registration, renewal registration, notification,
variation, food import recommendation application
To support the process of global regulatory system as required
To perform pharmacovigilance (PV) activities being one of PV members
To support some PV related activities in local literature search, case reporting submission,
Basic PV training etc;
To support medical information queries if required
To support in promotion material review process flow
To support product quality complaint handling and reconciliation procedure
Able to perform other assigned tasks as per departmental requirements

JOB DESCRIPTION:

B. Pharm (Bachelor of Pharmacy) preferred
At least 1-2years experience in regulatory affairs field
Must have strong knowledge of regulations, guidelines and update trend of regulatory
affairs field, mostly in drug registration
Knowledge on pharmacovigilance would be advantage
Preferred good communication with local health authority

OTHER REQUIREMENT:

Able to travel if required
Able to work in a team, as well as independently
Flexible and can easily adapt to learn new things at any situation
To be a talented, self-motivated, energetic, enthusiastic person

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