General Information
Job Advert Title: Nonclinical Regulatory Management Expert
Location: Tsukuba, Ibaraki
Division: Early Development and Translational Science
Employment Class: Permanent
Description
【募集の背景 / Purpose & Scope】
Purpose & Scope of Nonclinical Regulatory Management Lead (NCRM-L) are:
-To provide high-quality and efficient global non-clinical application-related works.
-To realize the presentation of scientifically valid and effective data packages, considering applicable regulatory requirements and regional review policies of authorities.
-To maximize the likelihood of approval by global health authorities, determine the best practice for non-clinical application-related activities, including strategies for study setting and documentation, in collaboration with related functions and other stakeholders.
-In addition to achieving the above Purpose & Scope in individual programs, NCRM-L senior manager is expected to take the role for process improvement of nonclinical regulatory submission-related works in the department/subdivision.
【職務の内容 / Essential Job Responsibilities】
（雇入れ直後）
Promote high-quality and efficient nonclinical application-related works in all programs in charge based on scientific experiences and insights.
-Work with stakeholders to develop and maintain lists of nonclinical studies required for IND/NDA.
-Develop and manage the timeline (including review and QC processes) for the preparation of nonclinical documents for regulatory submissions (clinical trial submissions and their updates, new drug application documents, authority consultation documents, responses to inquiries, periodic reports, etc.). within Research.
-Manage the ensuring the reliability of the document.
-Write a part of the submission documents based on individual expertise (pharmacology/pharmacokinetics/toxicology)
-Review application documents from a comprehensive perspective, including overall consistency and application strategies, and revise them in conjunction with authors in other functions.
-Provide internal/external information and know-hows on nonclinical application activities for project members, including pharmacology, pharmacokinetics and safety representatives.
•Contribute to agilely managing the quality of nonclinical activities for submission in collaboration/in-licensed programs working with nonclinical representatives and Research Lead as well as Directors in the Department.
•Contribute to accumulating information and know-how on internal and external nonclinical regulatory science, and sharing those with department members.
•Identify issues for productivity and quality in nonclinical application-related works, and contribute to resolving them in cooperation with Directors of the department and other stakeholders.
•May contribute to resolving division's operational issue.
•May lead Research extended team and participate in Core Team as a Reseach Lead of late-stage projects with supports from Directors in the department.
•May participate in external industry activities as a representative of the department.
（変更の範囲）
会社内での全ての業務
【応募要件 / Qualifications】
＜必須 / Required＞
•More than 7 years of nonclinical research experience or equivalent
•More than 3 years of nonclinical application work experience including preparation of application documents r equivalent
•Logical thinking ability
•Communication and leadership abilities
＜歓迎 / Preferred＞
•Advanced science degree (PhD) or Proven track record.
•Experiences on nonclinical works for obtaining approval of new drug application and/or clinical trial application.
【応募書類 / Application Documents】
和文履歴書（必須）・和文職務経歴書（必須）・英文レジュメ（任意）
Resumes
【選考プロセス / Selection details】
書類選考 → 1次面接 → 適性検査 → 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 → Aptitude test → Final interview
*Please be advised that there might be a change in the process.
【勤務地 / Location】
（雇入れ直後）
茨城県つくば市 アステラス製薬 つくば研究センター
Tsukuba, Ibaraki
※ＪＲひたち野うしく駅とつくばエクスプレス（TX) 研究学園駅より通勤バスがございます。
（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】
8:30～17:30（月～木）、8:30～15:45（金）、専門業務型 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。
8:30～17:30（Mon～Thu）、8:30～15:45（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."