Job Advert Title: Director CCDS Labeling Strategy
Location: Nihonbashi, Tokyo
Division: Regulatory Affairs
Employment Class: Permanent
Description
【募集の背景 / Purpose & Scope】
In collaboration with strategic regulatory, this position will be responsible for regulatory leadership and support (both technical and operational) in the area of CCDS (Company Core Data Sheets) and product labeling for key market products in all primary focus areas. This will include new products and life cycle management of existing portfolio. This position will function as a CCDS Labeling Lead for a key market product and will be responsible for all aspects of CCDS labeling development including creating, updating, and maintaining labeling content documents throughout the product lifecycle. This position will help maintain controlled records for historical, current and ending labeling changes. This position will manage labeling content review and approval process applying regulatory, therapeutic area and clinical knowledge to the process.
This position will have the responsibility of the CCDS Labeling Lead, providing oversight to other Regulatory personnel including CCDS Labeling Leads (CLL) who are responsible for developing or managing CCDS and labeling content and ensuring consistency across product labels. As needed, this position will also help to implement process improvement changes to increase the efficiency and effectiveness of the label review process.
【職務の内容 / Essential Job Responsibilities】
（雇入れ直後）
Key responsibilities include development of target product labels, CCDS and label development and supporting the development of key major markets Labeling across Astellas products. This position will also be responsible for ensuring quality documentation processes and QC of all labeling documents.
This position will function as a CCDS Labeling Lead for products in all primary focus areas and will be responsible for all aspects of labeling development including creating, updating, and maintaining labeling content documents throughout the product lifecycle. This position will help maintain controlled records for historical, current and ending labeling changes. This position will manage labeling content review and approval process applying regulatory, therapeutic area and clinical knowledge to the process.
This position will also act as the Key Market Labeling Lead providing oversight to other Regulatory personnel including CCDS Labeling Leads (CLLs) who are responsible for developing or managing labeling content and ensure consistency across product labels. As needed, this position will also help to implement process improvement changes to increase the efficiency and effectiveness of the label review process. This position will be responsible for leading the creation, implementation and maintenance of the CCDS applying scientific and clinical knowledge to the process. The position will understand and incorporate all key labeling guidance’s, FDA, Health Canada, Pharmaceutical and Medical Device Agency (PMDA), National Medical Products Administration (NMPA) and EU guidance’s into labeling strategies for those regions.
This position will be able to liaise with key regulators, FDA, Health Canada, PMDA, NMPA, and EMA for formal written and verbal negotiations. This position will participate in identification of risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans. This position will assess impact of new labeling regulations and implement appropriate changes as well as lead development of company policy and position on draft regulations and guidance. This position will interact cross-functionally with members of RA, asset team, commercial, legal, safety, medical and others.
（変更の範囲）
会社内での全ての業務
【組織 / Organizational Context】
This position will independently interface and effect decisions with local and global team members (e.g., Pharmacovigilance, Medical Affairs, and affiliates members). The position reports to the Executive Director, CCDS and Labeling, Regulatory Affairs. The individual may have direct reports at the Associate Director and Manager levels.
【応募要件 / Qualifications】
＜必須 / Required＞
• Bachelor's degree (preferably in a life sciences field) with preference to higher degree.
• Relevant experience in Regulatory Affairs in the area of labeling development and review for prescription pharmaceuticals or similarly regulated industry required (10 + year of relevant experience).
• Excellent planning, organizational, analytical, problem-solving, and decision-making skills.
• Ability to lead and motivate others.
• Ability to drive projects to completion.
• Possesses a working knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in the area of product labeling and packaging.
• Ability to exercise sound judgment and operate with a high degree of independence regarding routine and non-routine assignments.
• Possesses excellent written and verbal communication skills.
• Strong computer skills, including a working familiarity with electronic document management systems for compliant maintenance and version control of submitted, approved and in-use labeling.
• Proficiency in a second language is a plus.
＜歓迎 / Preferred＞
• Advanced degree (e.g., Masters, PhD, etc.,)
• Scientific knowledge in chemistry, general biological/physical science and ability to apply that knowledge to regulatory issues and product development having technical complexity.
【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】
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】
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."
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