募集要項
- 募集背景
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Hiring background：New role due to reorganization.
*One of the best companies in the pharmaceutical industry for work/life balance.
*Remote work is available: The company is promoting hybrid work, combining working from home and in the office.
- 仕事内容
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RA-CMC Global Approved Product Lead【業務内容】
グローバル組織への組織変更による増員
・日本・APAC地域のCMC薬事責任者として、市販後プロジェクトのライフサイクル全般において、グローバルCMC戦略の策定に関わり、担当地域におけるコンプライアンスを遵守した申請及び照会対応、並びに当局対応をリードする。
・日本（可能であればAPAC地域も）のCMC薬事専門家として、初回申請や市販後変更管理、安定供給、リスク管理に関与し、適宜提言・助言・支援を行う。
・他部署、外部パートナー、規制当局などの様々な関係先との業務において、強力なリーダーシップをもって影響力を発揮するとともに、自組織の継続的改善や知識の共有・浸透などの薬事力の維持強化にも貢献する。
The role independently leads global RA CMC activities for approved products from preparation of the first marketing application through the full post-approval lifecycle. Acting as the primary JP/APAC CMC regulatory lead, the role is accountable for developing global and executing regional CMC regulatory strategies, ensuring high-quality, compliant submissions, and managing regional Health Authority interactions.
The position serves as a recognised RA CMC expert for a specific product type and/or country or region (JP essential, APAC desirable), providing authoritative regulatory insight that is leveraged across multiple global programmes. Responsibilities include leading on RA CMC activites for initial marketing applications, managing post-approval variations and lifecycle changes, supporting supply continuity, and proactively identifying and mitigating regulatory risks.
The role provides strong leadership and influence across cross-functional teams, external partners, and Health Authorities, supports inspections, audits, and due diligence activities, and contributes to continuous improvement, knowledge sharing, and capability building within the global RA CMC organisation.
- 応募資格
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- 必須
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【必要な業務スキル、経験】
【必要要件】
・10年以上の製薬業界経験（うち直近3年以上の薬事経験）
・CMC薬事担当者として、市販後製品のライフサイクル全体におけるグローバル薬事戦略の策定に関与した経験
・日本当局への申請や申請後対応（照会対応の実務）の経験
・社内外（海外を含む）担当者との協働経験
【尚可要件】
・APAC地域のCMC薬事業務経験
※日本での薬事経験を重要視しますが、グローバル品を日本で対応していただく業務を想定していますので、海外の薬事に関する知識のある方が有利です。
Position Requirements：
The role requires extensive experience in pharmaceutical Regulatory Affairs CMC, with a strong focus on approved and marketed products. Candidates must demonstrate the ability to independently develop and execute global CMC regulatory strategies across the post-approval lifecycle, including initial marketing applications, variations, and change management.
Deep expertise in CMC regulatory requirements in JP is essential (APAC desirable), along with proven experience interacting with JP/APAC Health Authorities on CMC-related matters. The role demands strong regulatory judgement, leadership without formal authority, and the ability to influence complex cross-functional and global stakeholders.
【語学要件】
日本語：母語もしくはそれに準じる読み書き能力
英語：英語会議で議論をリードしたり、高度な交渉をすることが可能なビジネスレベル
■Language skill:
Japanese:Native-level Japanese proficiency
English：Capable of leading discussions and negotiations with global stakeholders in English
- 募集年齢(年齢制限理由)
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Up to 45 years old
（定年年齢を上限として募集するため）
- フィットする人物像
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【求める人材像】
・高い対人スキルとコミュニケーション能力
・グローバルな視点を持ち、多様な地域・文化と協働できること
・複数の重要タスクを同時並行で主体的に責任感を持って管理する能力
・課題やリスクを抽出し、解決に向けた戦略・対策の立案及び実行を関係者と協働して進められること
・非喫煙者【必須項目】
※当社では「社員一人ひとりの健康で質の高い豊かな人生の実現」を目指して健康経営に取り組んでおります。その一環として、全応募者の方に関しまして、「非喫煙者」を必須条件とさせていただきます。
面接時にも採用担当者よりヒアリングをさせていただく予定です。
Key Competencies specific to the role:
Excellent communication, organisational, and problem-solving skills are required, together with a proactive, accountable mindset and the ability to manage multiple priorities independently in a global environment.
Our Group strives for Health ＆ Productivity Management aiming to “deliver good health, quality and well－being in each employee’s life.” We would like to request all the applicants for our mid－career recruitment to observe the following [Essential requirement]. We would appreciate your kind understanding.
[Essential requirement： Nonsmoker］
- 雇用形態
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Full-time employee
*6 month trial period
- ポジション・役割
- Pharmaceutical Affairs Department/ AC-MC Group Lead (Line -manager)
- 勤務地
- Tokyo (Chiyoda-ku)
- 勤務時間
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A super flextime system: Working hours: 3-hours between 7:00 and 20:00 (no core time, working hours: 7 hours 40 minutes)
*Remote work available: Guideline: Coming to the office 3 days a week.
- 年収・給与
- 7 million yen ～ 13 million yen
- 待遇・福利厚生
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Benefits: Social insurance (health insurance, nursing care insurance, employee pension insurance, employment insurance, workers' compensation insurance), various savings plans, residential sub-lending loan plan, group welfare association, corporate pension, defined contribution pension, welfare services, various group insurance
Other: Housing subsidy, babysitter subsidy, nursing care leave, leave due to spouse's transfer, MR cohabitation support system for marriage and childbirth, family support allowance, return employment system
*Smoking is completely prohibited in the company
*There are also systems for shortened working hours for childcare and shortened working hours for nursing care.
- 休日休暇
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Sundays, national holidays, Saturdays, New Year's holiday (12/29-1/3), 125 days off per year, 2 days off per week
Paid leave: 15-20 days depending on years of service
Other: Comprehensive systems for spousal maternity leave, maternity leave, and childcare leave.
- 選考プロセス
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Document Screening* ⇒ First Interview ⇒ SPI Test ⇒ Final Interview
*Both Japanese and English CV are required.（日本語・英語CV共に必須）
Online interviews will be conducted.
Note:
1. Scope of changes in work to be performed: You may be ordered to perform all work within the company.
2. Scope of changes in place of work: You may be ordered to transfer to all of our business locations and to other companies, corporations, or organizations (including places where you can work from home) as secondments or dispatches. Places where you can work from home include your own home, your own or your spouse's parents' home, or your spouse's home (however, working from home is only permitted if the company approves it).
