Site Name: Japan - Tokyo - Akasaka Posted Date: Jan 21 2025 職務の目的 規制当局及び社内関連部署と良好な関係を築き、規制当局との窓口業務を適切に遂行し、承認前GMP適合性調査、定期的なGMP適合性調査及び外国製造業者認定の新規取得／管理を確実に行う。 主な業務内容 下記業務における規制当局窓口業務（申請・照会事項対応） 新薬申請時の承認前GMP適合性調査 一部変更承認申請時の承認前GMP適合性調査 定期GMP適合性調査 外国製造業者認定　新規申請・更新・変更 必要な条件 海外と口頭でコミュニケーションができる最低限の英語力（リスニング、スピーキング）（TOEIC600点～） 社内関連部署及び当局と交渉するためのコミュニケーション能力 スケジュール管理能力 製薬業における業務経験 リーダーシップ 望ましい条件 高度な英語力（TOEIC700点～） 医薬品製造・品質保証に関する知識・経験 医薬品製造販売承認申請書に関する知識・経験 GMPに関する知識・経験 ピープルマネジメントの経験 Why GSK? Uniting science, technology and talent to get ahead of disease together. 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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). 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.