Regulatory Affairs Executive

Regulatory Affairs Executive

a im lm vic 326 L Thng Kit, Qun 10, HCM

GII THIU CNG TY

Chng ti l nh my sn xut dc phm, m phm v sn phm chm sc sc khe theo tiu chun GMP-WHO, GMP-EU v PIC/S. Vi cam kt cung cp cc sn phm cht lng cao, chng ti lun n lc khng ngng pht trin v m rng th trng. i ng nhn vin ca chng ti l s kt hp ca nhng chuyn gia giu kinh nghim v nhit huyt, to nn mi trng lm vic sng to v hiu qu.

1. M t cng vic

RA (Regulatory Affairs) Specialist chu trch nhim qun l v m bo s tun th cc quy nh php l lin quan n ng k, sn xut, v lu hnh sn phm dc phm. Cng vic bao gm:

ng k sn phm:

Son tho h s ng k, h s thay i, b sung, gia hn; phi hp vi n v thnh vin kim tra, chnh sa hon thin h s ng k sn phm nh k hoc khi c pht sinh trong phm vi c giao.

Cp nht thng xuyn cc thng t, cng vn ca Cc Qun l Dc lin quan n mng ng k (quy nh lin quan n ng thuc, k khai gi, thu, qun l cht lng).

Thc hin cc cng vic c lin quan ti ng k thuc, thc phm chc nng theo ng quy nh php lut, quy trnh ca cng ty.

X l cc vn pht sinh trong qu trnh lu hnh sn phm.

Phi hp theo di v thc y tin h s ng k ti c quan qun l m bo k hoch ra.

2. Yu cu cng vic

Tt nghip i hc chuyn ngnh Dc hoc cc ngnh lin quan.

-C t nht 1 nm kinh nghim trong lnh vc ng k thuc (RA).

-Am hiu quy nh php lut v ng k thuc, tiu chun GMP, GSP, GDP.

-Kinh nghim lm vic vi c quan qun l nh Cc Qun l Dc, B Y t l mt li th.

-K nng lm vic nhm, gii quyt vn , giao tip v qun l thi gian tt.

-C kh nng c hiu v vit ti liu chuyn ngnh bng ting Anh.

3. Quyn li

-Mc lng cnh tranh, thng theo hiu sut.

-c o to chuyn mn v pht trin ngh nghip.

-Mi trng lm vic chuyn nghip, c c hi lm vic vi cc chuyn gia trong ngnh.

-Cc ch bo him, phc li theo quy nh ca cng ty.