General Information

Job Advert Title: Senior Manager, Regulatory Labeling

Location: Nihonbashi, Tokyo

Division: Regulatory Affairs

Employment Class: Permanent

Description

Essential Job Responsibilities
- Responsible for development, implementation, and change control of new and revised labeling for assigned Astellas products and areas within the Rest-of-World (ROW) region.
- Ensures compliance with Company Core Data Sheets, applicable regional health authority requirements, and internal procedures and alignment with business needs.
- Researches government initiatives related to labeling and packaging, and assures that Astellas adopts new initiatives according to prescribed timelines.
- Requires significant interaction outside the Regulatory Affairs department on complex issues and questions.
- Maintains a positive working relationship with global internal stakeholders and business partner.


Qualifications

Required

- Drives labeling development for regional product launches and ensures that all labeling meets company and regulating health authority specifications.
- Manages English Master files and translation of text into local languages according to individual country requirements (where appropriate).
- Serves as leader of cross-functional labeling review team meetings; organizes, compiles, and maintains all documentation and assures compliance of manual and electronic label history files.
- Assures compliance of local labeling by evaluating all CCDS/CCSI changes and implementing according to prescribed timelines.
- Advises cross-functional teams on labeling content consistency and best practices regarding planning and execution.
- Collaborates with Regulatory Affairs cross-functional teams on submission and implementation strategy for labeling.
- Actively supports the systems, processes, and operations for development of and changes to labeling, and assures compliance to those procedures.
- Establishes strong working relationships with global stakeholders, affiliates, and business partners to assure compliant and timely implementation into business supply.
- Makes and executes challenging decisions based upon sound regulatory knowledge, but also recognizes when a decision should be elevated to upper management for further consideration.
- Keep management apprised of critical issues which may impact the success of the organization.


Preferred
- Bachelor’s or MS Degree in Pharmacy or other Life Science or equivalent by experience.
- At least 6 years previous industry experience; 3 years in Regulatory Affairs, including working within a global environment.
- Direct pharmaceutical labeling development experience required with demonstrated proficiency in managing change control.
- Experience with managing projects and working within a matrixed organization.
- Knowledge of Regulatory landscape, systems and procedures for CCDS and Labeling.
- 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.




【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50,000~100,000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】
年一回
Once a year


【賞与 / Bonus】
年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)、8:45~16:00(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
8:45~17:45(Mon~Thu)、8:45~16:00(Fri)
Discretionary Work System


【休日 / Holidays】
完全週休2日制、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


【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."