Regulatory Affairs Executive – Hanoi

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CÁC PHÚC LỢI DÀNH CHO BẠN

Annual Performance Bonus; 13th month salary
AON healthcare
Laptop

MÔ TẢ CÔNG VIỆC

Prepare the registration dossier to comply with local regulation / Check and request additional document to HQ / Submit the registration dossier and follow up with DAV officers, experts to get the results in timely manner for assigned products . It includes the new registration /renew/ variation/ new indication or any changes related to assigned products. It also includes of post approval to make sure the new approval to be implemented in timely manner
Co-ordinate with medical team to update PI for assigned products (including getting approval from DAV, implementation to commercial stock)
Coordinate with person in charge of local content to get approval of drug label for assigned products and do checking labeling compliance
Co-ordinate with Supply Chain manager to declare the registration price for assigned products
Prepare and apply the application and necessary formalities to get the registration samples for assigned products
Fill in Grass Form, Record of Registration Number, MA, approved PI & artworks; approved indications… Control the CPP, GMP, trade mark certificate, power of attorney, plant master files of manufacturing for assigned products.
Prepare application for submission to list assigned products into the brand name list of MOH. Assist RA Manager to get approval
Prepare application for submission to list assigned products into GMP – EU of all manufacture. Assist RA Manager to get approval
Prepare and submit application for promotion material after receiving request PMs. Follow up with DAV to get approval
Support distributor on providing document for hospital tender and SIQ
Coordinate with quality person to implement local quality SOP (complaint, label compliance check, local redressing…)
Be responsible for implementing all RA process including the PV compliance in proper manner
Assist RA Manager on Registration Monthly Report. Quarter update on the list of registered products and registered indications. Quarter update of CPP status

YÊU CẦU CÔNG VIỆC

At least 2 years working in Pharmaceutical industry in Vietnam
Bachelor degree in pharmaceutical/medicine or related areas
Vietnam Pharmaceutical Industry
Familiar with Health Authority structure in VN
Good knowledge of RA policies and working structure of Roche
Regulatory and scientific knowledge
Team Work
Communication skills
Work independent with high accurate data and timely manner
Deliver Results
Solution orientation
Fluent in both written and spoken English and good PC skill

BÌNH LUẬN

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