General Information

Job Advert Title: CMC薬事シニアマネージャー

Location: Nihonbashi, Tokyo

Division: Regulatory Affairs

Employment Class: Permanent

Description

Purpose & Scope

This position plays a key role in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions.

This position is responsible for development and successful execution of CMC regulatory strategy in close collaboration with Global Regulatory Lead, and writing of CMC documents, for assigned products.

This position can act as the subject matter expert (SME) for Regulatory CMC and works in close collaboration with stakeholders.



Essential Job Responsibilities

・グローバルの薬事、製薬技術部門及びその他の関連部門と連携し、グローバルに新薬開発段階から承認申請及び承認後製品の変更管理に関わるCMC薬事業務全般を担当する。

・薬事申請のためのCMC薬事戦略の策定

・申請資料(CMC部分)作成における関連部門との調整及び資料のレビュー

・申請資料(CMC部分)の記載内容に関する関連部門との協議及び調整

・グローバルのCMC承認情報の管理

CMC薬事関連の照会事項、その他の問題に対する対応

・承認申請~市販後変更に関わる薬事要件の収集、格納及び情報共有


Responsible for overall CMC regulatory activities throughout development, NDA and post approval CMC change globally.

Establishing CMC regulatory strategy for regulatory submissions

Communication and collaboration with relevant departments for preparation of CMC sections of regulatory dossier, and the document review.

- Coordination of cross functional discussion for CMC section of regulatory dossier

Maintenance of CMC approval contents globally

Dealing with information request from HAs and other CMC issues

- Contribute to collecting, interpretation, archiving, and knowledge sharing of regulatory requirements for both BLA/MAA and post-approval submissions



Qualifications

・申請資料及び当局照会事項回答作成を行う文章作成能力が高い。

・国内外の他の機能と連携してプロジェクトを推進する能力を備えたコミュニケーションおよび調整スキル

・業務上必要な英語の読み書きと会話ができ、さらに上達意欲がある。

(目安:TOEICスコア730点以上か、同程度のスコアを近い将来に達成する意欲のある方)


- Effective writing skill for submission documents and response documents to be submitted to HAs.

- Communication and coordination skills with the ability to carry out projects by collaborating with other functions inside and outside of Japan

- English reading, writing and speaking skills with a motivation for further improvement (TOEIC score of 730 or above)


Required

・理系大卒以上

8年以上の医薬品業界における経験、及び薬事部門若しくはCMCの薬事対応の責任を担う部門での3年以上の実務経験、若しくは同等の経験を有する。

・プロセス開発、分析、プロセスのスケールアップなどの経験、原薬または製剤(経口および非経口剤形を含む)の薬事上の経験を有する


- BS in Chemistry/Pharmaceutics or equivalent degree

- 8+ years industry experience with at least 3 years experience directly in Regulatory Affairs or in CMC regulatory or role with CMC regulatory submission responsibilities in CMC related functions.

- Experience with process development, analytical research, process scale-up and/or regulatory registration of drug substances or drug products.


Preferred

バイオ医薬品に関わる実務経験

Experience in biologics products



【応募書類/Application Documents】
和文履歴書・和文職務経歴書・英文レジュメ
Both Japanese and English Resumes are needed


【勤務地 / Location

東京都中央区 アステラス製薬 日本橋事業所 本社

Nihonbashi, Tokyo



【勤務開始日 / Start Date

応相談

Will be decided according to the candidate's flexibility



【契約期間 / Contract Duration

期間の定めなし

Not limited to specified period



【試用期間 / Probation Period

試用期間原則なし

No probation period in principle



【給与 / Salary

①基本給:当人の経歴・技術・技能等を考慮して決定

②裁量労働制の場合:裁量労働手当として職務グレードに応じて50,000100,000円支給

③フレックスタイム制の場合:月間の所定労働時間を超えて勤務する時間に対して時間外勤務手当を支給


①Base salary: will be decided by the candidate's experience, skill and capability.

②When Discretionary Work System is applied: Discretionary work allowance will be paid.(50,000~100,000yen, based on the Grade)

③When Flextime System is applied: Overtime allowance will be paid for time worked in excess of prescribed working hours.



【昇給 / Salary Raise

年一回

Once a year



【賞与 / Bonus

2回(7月、12月)

Twice a year (July, December)



【諸手当 / Allowance

裁量労働手当、住宅手当、通勤手当 等

Discretionary work allowance, Housing allowance, Commutation allowance, etc.



【勤務時間 / Working Hours

8:45~17:45(月~木)、8:4516:00(金)、企画業務型 裁量労働制

裁量労働制の場合、所定労働時間を働いたものとみなす

8:45~17:45MonThu)、8:4516:00Fri

Discretionary Work System



【休日 / Holidays

完全週休2日制、祝日、51日、夏季、年末年始

Weekends(Sat and Sun), holidays, May 1st, summer vacation, New Year holidays



【休暇 / Vacation Leave

年次有給休暇、育児休業制度、介護休業制度 等

Annual paid leave, childcare leave system, nursing care leave system, etc.



【福利厚生 / Welfare

雇用保険、労災保険、厚生年金、健康保険、共済会制度、社宅制度、持株会制度、財形貯蓄制度 等

Employment Insurance, Industrial Accident Compensation Insurance, Welfare Pension Insurance, Health Insurance, Mutual Aid Association System, Company Housing System, Employee Shareholder Association System, Property Accumulation Savings System



【お問い合わせ / Contact

アステラス製薬株式会社 採用担当 / Japan Recruiting team, Astellas Pharma Inc.

astellas.recruit@jp.astellas.com

※本職種についてのご質問は、上記までお問い合わせください。


"We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law."