Drug Registration Specialist药品注册专员社

面议

宜昌市本科及以上

发布时间：2023-09-06

职位描述

职位描述：

JOBDESCRIPTION:TheDrugRegistrationSpecialistwillberesponsiblefortheleadershipandsupportoftheRegulatorypersonnel.He/shewillparticipateinallactivitiesrelatingregistrationrequirementsandlineextensionindications.

JOBRESPONSIBILITIES:
-Responsibleforcompilation,submissionandfollowthroughapplicationsofdrug/otherregistrationdossiers,fornewandmarketedproductsandlicenserenewalswithinthesettimeframe,andincompliancewithlocalregulatoryagencyrequirements;
-Aggregateinformationanddraftproductstandardsondrug;
-Trackandfollowthroughregistrationprojectdevelopment;
-Establishgoodworkingrelationshipwithregulatoryagencies/institutions,internalteammemberstoensureeffectiveproductregistrations;
-Providerelevantregulatorysupports;
-Handleotherissuesduringtheprocessofdrugregistration.

REQUIREDQUALIFICATIONS:
-Bachelor'sdegreeinPharmacy/Bio-pharmaceuticals/Bio-chemistryorarelatedscience;higherdegreeisaplus;
-Atleast3yearsofworkexperienceindrugproductregistrationsworkingatahighlevelofcompetencywithamajorpharma;
-SolidknowledgeofandexperienceinworkingwithSFDAregulation;
-FamiliaritywiththeregistrationapplicationprocedureofSFDAandrelatedlaws;
-Interpersonalrelationships,flexibility,adaptabilityandteamspirit;

-Customerserviceorientationandresult-orientedperson;
-GoodEnglishandRussianlanguageskills,bothwrittenandoral;
-Superiorcomputerskills(Work,Excel,PPT,etc).

Phone:0717-6345052

其他要求

招聘人数：1人
职能类别：

公司介绍

宜昌人福药业出口基地主要负责欧美固体口服制剂的出口。该厂完全按照美国FDA标准打造。现诚聘英才