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


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








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






- 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)





- 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.



Experience in biologics products

【応募書類/Application Documents】
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


Will be decided according to the candidate's flexibility

【契約期間 / Contract Duration


Not limited to specified period

【試用期間 / Probation Period


No probation period in principle

【給与 / Salary




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


Once a year

【賞与 / Bonus


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



Discretionary Work System

【休日 / Holidays


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.


"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."