Regional Ra Compliance Lead

【募集の背景 / Purpose & Scope】

Support the International/Greater China (INT/GCN) RA Head by providing compliance and operational oversight of and support to all regulatory activities in countries in respective region.For the operational aspect of the role, the focus is to support individual countries, whereas the RA compliance is focused on countries and regions - INT/GCN-RA HQ.

Support the Regional lead and the sub-regional leads in directing the affiliate RA function with the end goal to ensure:

- efficient, timely, high-quality product registrations

- compliance with all applicable guidelines and procedures

- efficient use of all global systems

- efficient and optimal completion of LMS training

【職務の内容 / Essential Job Responsibilities】

（雇入れ直後）

• Ensure Implementation/maintainance of regional or global affiliate RA quality documents and/or manuals.

• Implement/maintain guidance for the management of RA responsibilities of affiliates’ Business Partners.

• Support submissions and approvals as per targets

　• Support oversight of execution of the agreed regulatory action plan for compliance related submissions and approvals within the region.

　• Support countries to ensure compliance at the local level with global, regional and local policies and procedures.

　• Secure that the internal systems/tools are populated in line with the Astellas policies and procedures.

　• Support quality compliance of marketed products, in line with internal and local regulatory policies, as well as securing timely product re-registrations

　• Participate in the review and development of RA tools and systems, and provide training accordingly.

• Quality function

　• Support GxP audits at affiliate and regional level when related to RA Participate in the review and development of RA practices and policies, and provide training accordingly to regional RA HQ and the countries in scope.

　• Secure compliance of regulatory practices with the relevant SOPs through a quality self inspection and audit system.

　• Ensure processes efficiency, optimization and technical alignment across the region.

• Support the (sub)-regional RA leads in the management of the country RA function

　• Support AdPromo RA review activities as needed.

　• Coordinate training activities to ensure skill development in countries keeps pace with the need

for competitive regulatory strategy and company procedures.

　• Contribute to a seamless relationship and teamwork between assigned countries and the regional

HQ in order to establish best practices sharing and where possible, resources sharing.

　• Cooperate with other relevant departments regarding the implementation of specific programs

and tools, ensure consistent, robust processes in line with the Astellas standards.

　• Set up KPIs for ensuring that performance can be measured and continuous improvements can

be achieved.

（変更の範囲）

会社内での全ての業務

【応募要件 / Qualifications】

＜必須 / Required＞

• MS Degree in Pharmacy or other Life Science or equivalent by experience.

• At least 10 years Regulatory Affairs experience, including working at RA affiliate level

• Experience with managing projects and working within a matrixed organization.

• Knowledge of Regulatory landscape, systems and procedures within the region

• Proficiency in English language

• Excellent communication, influential, planning and problem-solving skills, along with the ability to build and manage close relationships with all relevant stakeholders

• Proven affinity and capability to work within teams where there is no direct reporting relationship .

＜歓迎 / Preferred＞

It is recognized that this role will require considerable regulatory and leadership experience, a good track record, and clear leader behaviours focused at collaboration & shared accountability

【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】

当人の経歴・技術・技能等を考慮して決定

Will be decided by the candidate's experience, skill and capability.

【昇給 / Salary Raise】

有り

【賞与 / Bonus】

有り

【諸手当 / Allowance】

住宅手当、通勤手当　等

Housing allowance, Commutation allowance, etc.

【勤務時間 / Working Hours】

管理監督者 8:45～17:45（月～木）、8:45～16:00（金）

Managers and Supervisors 8:45～17:45（Mon～Thu）、8:45～16:00（Fri）

【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."