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| 部署・役職名 | [Remote wk] Global Regulatory Affairs: Compliance ＆ Planning Manager（Tokyo） |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
[Responsibilities] The Global Compliance and Planning Manager will: －Lead or support Global SOP/Work Instruction （WI） WG, ensuring a defined set of global and/or regional/ local SOPs are in place as part of the SOP roadmap. Ensure there are optimised processes for gap analysis, governance, and implementation of priority 1, 2 and 3 SOPs/WIs. The role will involve working across Sub－functions globally within GRA, and with stakeholders outside of GRA. －Global Risk Register WG, ensuring processes are in place that support the Global Risk Register WG’s implementation of regulatory risk identification, tracking and mitigation steps to allow for greater optimisation, metrics development and reporting to management. The role will involve implementing an optimised communication plan to allow for relevant risks are shared with appropriate stakeholders. －Lead or support the cultivation of a framework for Compliance and Planning metrics development and execution. Activities also include development of framework for Compliance and Planning Sub－function collaboration with other Sub－functions in reporting the status of GRA metrics to GRSC. Further this role will support the provision of strategic advice on implementation of mitigation strategies. －Ensure implementation and maintenance of other Compliance and Planning initiatives, such as training matrices and inspection readiness within a region. Related to inspections, activities may include attendance, preparation and follow up on inspections/audits on a regional and global basis. |
| 労働条件 |
Full－time employee, with 6 month trial period Position＆role：Global Regulatory Affairs Division Manager （Managerial） Expected annual salary （as guideline）: 7 million yen ～ 14 million yen ＊Annual salary will be considered based on the individual's age, ability, experience, and duties. Work location: Head office （Chiyoda－ku, Tokyo） Working hours: ＊Super flex system implemented. Work 3 hours between 7:00 and 20:00 （no core time, regular working hours: 7 hours 40 minutes） ＊Hybrid work is promoted: Come to the office 1－3 days a week. Full remote work is not currently possible. ＊Other systems are available for short－time work for childcare and short－time work for elderly care. Benefits and welfare: Benefits: Social insurance （health insurance, nursing care insurance, employee pension insurance, employment insurance, workers' compensation insurance）, various savings plans, residential loan system, group welfare association, corporate pension, defined contribution pension, welfare services, various group insurance Other: Housing subsidy, babysitter subsidy, nursing care leave, leave due to spouse's transfer, MR cohabitation support system at marriage and childbirth, family support allowance, return employment system ＊Certified for 8 consecutive years since the establishment of the METI ”Health and Productivity Management Excellent Corporation 2024 （White 500）” system. Holidays and holidays: Sundays, holidays, Saturdays, New Year's holidays （12/29－1/3）, 125 days of holidays per year, 2 days off per week Paid leave: 15－20 days depending on years of service, Other: Spousal maternity leave, maternity leave before and after childbirth, and childcare leave systems are available. Selection process: Document screening ⇒ First interview ⇒ SPI aptitude test ⇒ Final interview ＊ Please submit an English CV when applying. ＊ Part of the final interview will be conducted in English. ＊ Both the first and final interviews will be conducted online （Zoom）. Note: 1. Scope of changes in work to be performed: You may be ordered to perform all work within the company. 2. Scope of changes in place of work: You may be ordered to transfer to all of our business locations and to other companies, corporations, or organizations （including places where you can work from home） as secondments or dispatches. Places where you can work from home include your own home, your own or your spouse's parents' home, or your spouse's home （however, working from home is only permitted if the company approves it）. |
| 応募資格 |
【必須（MUST）】 [Required skills and experience]■Education ーBachelor's degree （science discipline preferred）. Further relevant qualification desirable. ーAt least seven or more years’ experience in the pharmaceutical industry.Practical experience working in a global team is desirable. ■Technical Skills ーDetail oriented. ーProject management skills. ーAbility to understand regulatory and technical concepts and requirements. ーUp－to－date knowledge of both existing and emerging regulatory guidance and sciences related to labelling or compliance and planning. ーGood working knowledge of Microsoft Office required. ーPrior experience with assessing change controls. ■Physical Requirements ーPosition may requires approximately 5％ domestic and international travel. [Language requirements] <MUST> － Business level or higher English proficiency （able to lead meetings in English and actively engage in intercultural communication or not feel uncomfortable with it. ） －Ability to read, write and communicate in English （TOEIC score of 800 or above） －Ability to communicate in Japanese. ＊Part of the final interview will be conducted in English. [Desired talent profile] ーCultural sensitivity is essential and the ability to develop consensus within a multinational organisation necessary. ーBroad level of interpersonal skills, leadership ability and flexibility also necessary. ーExcellent collaboration skills needed. ーExcellent problem－solving skills also needed. ーExcellent written and oral communication skills needed. －Non－smoker（must） |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2025/05/04 |
| 求人番号 | 4627483 |
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