General Information

Job Advert Title: Regulatory Operations Associate Director

Location: Nihonbashi, Tokyo

Division: Regulatory Affairs

Employment Class: Permanent

Description

【Purpose & Scope】

Regulatory Operations - a group within the Regulatory Affairs Department - consists of three areas: Publishing and Submission, Regulatory Product Information Management, and Data Integration and Optimization (DIO).

This Position applies within Regulatory Operations of Data Integration and Optimization. The DIO Associate Director is expected to be an expert in this area and should have substantial knowledge of the other two Regulatory Operations areas and how they relate to one another, how our Regulatory systems interact, and how they interface with other aspects of the Astellas' information ecosystem.

 Responsibilities involve organizing underlying informatics aspects of projects/products, including the data elements used in submission planning among different systems, registration management and both document- and data-centric submissions to regulatory agencies and establishing relationships with key personnel within the global Regulatory Affairs organization to identify process improvements.


This position also involves the following aspects:

・Incorporates industry specifications/initiatives into our processes and deliverables

・Contributes to and sometimes leads cross-functional and/or industry initiatives including IT system implementations and process re-engineering projects, capable of representing all of Regulatory Operations.

・Proactively resolves complex and diverse business problems with decision-making that impacts area of responsibility and Regulatory Operations as a whole

・Manages one's own tasks and deliverables in alignment with his or her line manager

 


【Essential Job Responsibilities】

・Contributes to Regulatory Operations strategy by implementing actionable plans for near- and long-term process improvements involving RA systems as well as interactions with other functions such as Supply Chain, Pharmaceutical Technology or Pharmacovigilance.

・Leads or participates in cross-functional initiatives involving regulatory information, with particular emphasis on integrations with systems outside of RA, shared information taxonomies and data dictionaries

・Leads or participates in industry working groups to represent Astellas, often in collaboration with other RA members including Regulatory Intelligence colleagues, spanning information needs for all RA functional departments

・Liaises with Information Systems and other Planning and Administrative functions on a variety of topics including platform strategies and IT roadmap prioritization

・Tracks alignment of operating models across all concerned RA functional departments (Therapeutic Areas, Affiliates, CMC, Regulatory Intelligence, CCDS & Labeling, Regulatory Operations, Planning and Administration, Compliance and AdPromo groups) during vendor/system selection activities, while preparing for new/major system implementations, and when evaluating ongoing process improvement opportunities in steady state

 

 

【Organizational Context】

・Reports to a Director or Sr. Director of Regulatory Operations

・Line manager may be in another geographic location

・May have line management responsibility, within the same office location where possible

・Peers are other global Regulatory Operations staff to promote sense of one Reg Ops team


 

 【Specific Physical or Environmental Requirements】

Working location will be the regional headquarters of the residing country. Occasional travel to relevant conferences or team members in other regions.

Due to the global nature of the position, availability for early morning meetings (in USA) or late night meetings (in JP) is required.

 


 【Required】

・Bachelor’s degree (science or technology is preferred)

・At least seven 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

・Proven ability to coordinate priorities and tasks across project teams, committees, etc. to attain group objectives

・Proven ability to anticipate and proactively resolve project or procedural issues

・Demonstrated experience championing new processes and leading change management activities

・If managing staff the incumbent should have experience managing people and/or teams or otherwise demonstrate the ability to do so

・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

・Ability to keep calm under pressure

 

【Preferred】

・Advanced degree (e.g., Masters, PhD, etc,)

・Experience with managing IT systems

・Proven expertise in document management, submission publishing, registration management, labeling, quality control and/or change control systems

・Experience in defining or interacting with information taxonomies, master data management or other structured data constructs

・Experience with data warehousing, data lakes and reporting/analytics platforms

・Proficiency in other language(s) – most common/useful are Dutch, Japanese, Spanish, Portuguese, French, Russian, Chinese



【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)、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."