Regulatory?Affairs?Specialist?for?API?and?Finished?Dosage?Form?registration?in?ChinaPosition?Summary:?The?regulatory?affairs?specialist?will?be?a?part?of?a?very?professional?and?dedicate?global?regulatory?group?of?31?persons?placed?in?Denmark,?US,?Hungary,?Japan,?India,?Croatia?and?China.?You?will?be?working?from?the?Xellia?office?in?Shanghai.?The?position?involve?traveling?activities?to?our?API?manufacturing?facility?in?Taizhou?on?monthly?basis.?The?regulatory?affairs?specialist?is?expected?to?take?a?leading?role?in?registering?and?life?cycle?management?of?APIs?and?potentially?Finished?Dosage?Forms?on?the?Chinese?market?and?to?closely?follow?the?changing?regulatory?environment?in?China?ensuring?that?the?Xellia?filings?are?always?complying?to?the?regulations.Recruiting?Qualification?for?RA?person1.?Minimum?a?Bachelor?degree?in?pharmacology,?chemistry?or?other?relevant?natural?science??2.?Minimum?5?years’?experience?in?API?and?Drug?Product?(?preferably?injectables)?registration?in?China.3.?Very?good?English?written?as?well?as?oral?skills?4.?Very?good?GMP?understanding5.?Experience?with?fermentation?based?API?production?is?an?advantage6.?Team?player?with?good?communication?skill?and?the?ability?to?be?self?motivated??7.?Be?honest?and?open?minded.??????????注冊專員職位描述：注冊專員將成為由?31人組成的，分布于丹麥、美國、匈牙利、日本、印度、克羅地亞和中國的專業(yè)團隊的一員。你將在Xellia上海辦事處工作，同時涉及每月到Xellia位于臺州原料藥生產(chǎn)廠的出差任務(wù)。?注冊專員應(yīng)當(dāng)具備原料藥注冊及生命周期管理的主要責(zé)任，并能夠承擔(dān)未來制劑在中國市場的注冊工作，能夠密切關(guān)注不斷變化的中國法規(guī)環(huán)境，確保Xellia公司法規(guī)的合規(guī)性。注冊專員的招聘條件藥學(xué)，化學(xué)或其它相關(guān)自然科學(xué)學(xué)科的本科及以上學(xué)歷至少有5年原料藥和制劑（最好?注射劑）中國注冊經(jīng)驗很好的英文書寫能力和口語技巧對GMP具備很好的理解有以發(fā)酵為基礎(chǔ)生產(chǎn)原料藥經(jīng)驗者優(yōu)先考慮具備團隊合作精神，良好的溝通技巧并能夠自我激勵誠信和開放的態(tài)度?????備注：請投遞中英文簡歷。