Job Advert Title: Labeling Manager, ROW
Location: Nihonbashi, Tokyo
Division: Regulatory Affairs
Employment Class: Permanent
Description
【募集の背景 / Purpose & Scope】
ROW Labeling Manager position is responsible for development, implementation, and change control of new and revised labelling for assigned Astellas products and areas. Ensures compliance with Company Core Data Sheets, applicable regional health authority requirements, and internal procedures and alignment with business needs. Research government initiatives related to labelling and packaging, and assures that Astellas adopts new initiatives according to prescribed timelines. Requires significant interaction outside the Regulatory Affairs department on complex issues and questions. Maintains a positive working relationship with global internal stakeholders and business partners.
【職務の内容 / Essential Job Responsibilities】
（雇入れ直後）
• Leads labelling development teams for regional product launches and ensures that all labelling meets company and regulating health authority specifications.
• Manages English Master files and translation of text into local languages according to individual country requirements (where appropriate).
• Serves as leader of cross-functional labelling review team meetings; organizes, compiles, and maintains all documentation and assures compliance of manual and electronic label history files.
• Assures compliance of local labelling by evaluating all CCDS/CCSI changes and implementing according to prescribed timelines.
• Advises cross-functional teams on labelling content consistency and best practices regarding planning and execution.
• Collaborates with Regulatory Leads on submission and implementation strategy for labelling.
• Actively supports the systems, processes, and operations for development of and changes to labelling, and assures compliance to those procedures.
• Establishes strong working relationships with global stakeholders, affiliates, and business partners to assure compliant and timely implementation into business supply.
• Makes and executes challenging decisions based upon sound regulatory knowledge, but also recognizes when a decision should be elevated to upper management for further consideration. Keep management apprised of critical issues which may impact the success of the organization.
（変更の範囲）
会社内での全ての業務
【就業環境に関する要件 / Specific Physical or Environmental Requirements】
• At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
【応募要件 / Qualifications】
＜必須 / Required＞
• Bachelor's degree.
• At least 6 years previous industry experience; 3 in RA.
• Direct pharmaceutical labelling development experience required with demonstrated proficiency in managing change control.
• Proven proficiency with health authority regulations & guidelines (e.g. ICH) for labelling development, implementation, and compliance requirements, and applies understanding to business situations
• Proven effectiveness with stakeholders in the labelling system from content development through commercial supply
• Must be able to effectively influence peers and others both inside and outside the organization and maintain effective working relationships.
• Strong organizational skills and high level of attention to detail, with the ability to coordinate multiple large and diverse projects simultaneously.
• Excellent written and verbal communication skills (native and non-native English speakers).
High integrity with respect to maintenance of proprietary, confidential information
＜歓迎 / Preferred＞
• Bachelor's degree in scientific discipline; advanced degree preferred.
• Scientific knowledge in chemistry, general biological/physical science and ability to apply that knowledge to regulatory issues and product development having technical complexity.
【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
【選考プロセス / Selection details】
書類選考 → 1次面接 → 2次面接 → 最終面接
※変更の可能性もございますので、予めご了承下さい。
CV screening → First interview → 2nd Interview → Final interview
*Please be advised that there might be a change in the process.
【勤務地 / Location】
（雇入れ直後）
東京都中央区 アステラス製薬 日本橋事業所 本社
Nihonbashi, Tokyo
（変更の範囲）
会社の定める事業場および自宅
【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50,000～100,000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】
有り
【賞与 / Bonus】
有り
【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）、8:45～16:00（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
8:45～17:45（Mon～Thu）、8:45～16:00（Fri）
Discretionary Work System
【休日 / Holidays】
完全週休２日制（土曜・日曜）、祝日、5月1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
【アステラス製薬 採用サイト/ Career web site】
https://re-jp.astellas.com/jp/recruit/newgraduates/
For more information about Astellas, please visit our career web site.
"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."