CMC Regulatory Executive

Site Name: Japan - Tokyo - Akasaka Posted Date: Feb 7 2023 職務の目的および主な業務内容 Job Purpose & Key Responsibilities Responsibility: 新薬申請及び市販製品の変更管理におけるCMC薬事戦略を構築する 新薬申請及び市販製品の変更管理におけるCMCのレギュラトリーリスクを時宜特定し、対応策を立案する 高品質のCMC承認申請資料を作成する。 規制当局からの照会事項に対してタイムリーな回答作成を行う。 新薬申請及び市販製品の変更管理におけるタイムリーな承認に寄与する 最新のCMC薬事情報の把握と規制当局及び業界への高い影響力を持つ。 必要な条件Basic Qualification スキル Skill 英語により海外とのコミュニケーションのできる方（英語環境での理論構築、読み書き、会話力等） 戦略的かつ既成観念／セクショナリズムに囚われない十分な思考・企画立案能力 分析化学、有機化学または製剤・薬剤学（特に製造方法あるいはGMP）・生物学に関する十分な知識がある方 CMCに関わる各種ガイドライン及び日局等のCMC関連の豊富な知識を有する方 経験 Experience 企業でのCMC関連業務（分析、製造、CMC薬事）の３年以上経験のある方 学位/資格/語学力 Education/certification/Language 医学、薬学、生物学、物理科学等での学士もしくはそれと同等以上 望ましい条件 Preferred Qualification バイオ医薬品（ワクチンを含む）又は再生医療等製品の申請経験。 医薬品等の承認申請・対面助言関連業務。 スタッフ（後輩等）指導経験。 企業でのCMC関連業務（分析、製造、CMC薬事）5年以上の経験のある方。 修士、博士もしくはそれと同等以上 GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.