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 Regulatory Management Expert (RM-Expert) are: Enable efficient and high quality global nonclinical application-related works (strategic planning for application and documentation) by supervising and educating Research personnels from a high perspective based on the scientific and regulatory background as an application expert in a specialized field (pharmacology/pharmacokinetics/toxicology). Improve efficient access to useful internal/external information considering applicable regulatory requirements and regional review policies of authorities. Solve issues on application works in cooperation with each function.【職務の内容 / Essential Job Responsibilities】 （雇入れ直後） • Support and guide project personnels to plan and execute the nonclinical strategy in regulatory application, based on the background of scientific expertise in a specialized field (pharmacology/pharmacokinetics/toxicology) in cooperation with divisional Directors. • Contribute to collecting and analyzing information related to global nonclinical applications. and provide it to project personnel as appropriate. • Create application-related documents by exerting the expertise. • Review and support to revise the application documents which drafted by project personnel. • Contribute to providing educational input to personnels within and outside the department on nonclinical regulatory works. • Identify issues for productivity in nonclinical application-related works and solve them in cooperation with divisional Directors. • May play roles of NCRM-L as well as roles of Research Lead for late-stage programs. • May play operational roles in Division under delegation from Vice President and Senior Director. • May participate external industry activities as a representative of Research. • Contribute to improving the quality and efficiency of applications-related works in Research • Contribute to enhanced probability of project success by improving the quality of application strategies and document contents through education and support for project personnel. • Contribute to strengthen Astellas' presence within the industry and regulatory awareness.
（変更の範囲） 会社内での全ての業務
【組織 / Organizational Context】 Report to Head of Regulatory Management.
【応募要件 / Qualifications】 ＜必須 / Required＞ • More than 10 years of nonclinical research experience or equivalent • Substantial experience with over 8 years of nonclinical application works, including preparation of application documents. Willingness to perform and improve application-related works.• Good logical thinking. • High communication and leadership abilities.•Advanced science degree (PhD) or Proven track record.＜歓迎 / Preferred＞• Substantial 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 → 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） 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."