Job Advert Title: Partner, RA Regulatory Product Information Management
Location: Nihonbashi,Tokyo
Division: Regulatory Affairs and Pharmacovigilance
Employment Class: Permanent
Description
【募集の背景 / Purpose & Scope】
Responsibilities include organizing regulatory operations aspects of projects/products, including
- managing the planning, tracking of applications and other structured data to regulatory agencies,
- identifying and ensuring adherence to relevant submission standards,
- initiating/maintaining relationships with key personnel within the global Regulatory Affairs organization to resolve procedural and operational complexities and identify process improvements.
The position also involves strategic and execution-focused interactions with multiple regional health authorities and other Astellas functions such as Pharmacovigilance, Marketing Operations, Data Science, Supply Chain, Manufacturing, and other areas within Medical & Development.
The Senior Manager also serves on increasingly more significant project teams/task forces.
【職務の内容 / Essential Job Responsibilities】
（雇入れ直後）
• Supports the accuracy and completeness of global regulatory product data, metadata and other regulatory information in collaboration with data owners by authoring and/or reviewing the quality documents and other reference material and that adhere to the relevant data standards and industry best practices (i.e. Data Steward role)
• Supports the daily operation of the global Regulatory Information Management system including data entry, quality control and metrics by overseeing the vendor
• Supports and creates business processes to capture/track regulatory events/information into regulatory database according to local regulatory requirements
• Supports for ensuring regulatory information is provided to systems inside or outside of Regulatory Affairs & Pharmacovigilance (RAPV) according to system integration logic
• Supports controlled vocabulary management across RA systems, in conjunction with the RAPV Data Governance and Compliance team
• Delivers reports sharing Regulatory information with cross-functional stakeholders including RAPV, Medical Affairs, Development Operations, Finance and senior and top management
• Oversees the process and ensures the creation and transmission of data-centric regulatory submissions such as XEVMPD and IDMP
（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 (science or technology is preferred)
• At least five years’ experience in a regulatory operations role or similar position associated with regulated processes and content in the pharma industry
• Demonstrated accomplishments and/or education will be evaluated and substituted for extent of experience, as needed
• Ability to work independently with minimal direction and coordinate priorities and tasks within project teams, committees, etc. to attain group goal
• Proven ability to prioritize and multi-task with minimal supervision based on interactions with project team members demonstrate the ability to do so
• Ability to communicate effectively, establish and maintain productive working relationships, and influence peers and others in the organization
• Strong ability to communicate effectively in writing and verbally in English
• Ability to multi-task across multiple projects and deliverables
• High integrity to maintain confidential and proprietary information
＜歓迎 / Preferred＞
• Advanced degree (e.g., Masters, PhD, etc,)
• Experience with managing IT systems
• Demonstrated proficiency using registration management, labeling, quality control and/or change control systems
• Basic understanding of information taxonomies, master data management or other structured data constructs
• Basic understanding of data warehousing, data lakes and reporting/analytics platforms or concepts
• Proficiency in other language(s) – most common/useful are Dutch, Japanese, Spanish, Portuguese,French, Russian, Chinese
【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 → 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 → 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."