募集要項
- 募集背景
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Hiring background：
APAC（Asia‐Pacific）RA reorganization to fill global roles.
Job Purpose：
The Compliance and planning manager will ensure initiatives to support compliance and plannings mission are executed effectively to support the overall Global Regulatory Affairs Organization. This will include leading or supporting activities as follows:
Regulatory Compliance: Implement GRA Global Standard Operating Procedure (SOP) Working Group (WG) optimization of processes, which will help ensure there are a defined set of global and regional SOPs used within GRA, where the global SOPs support most of the ways of working. This is supplemented by regional or local SOPs/WIs where required (e.g. to support specific actions within a region).
ーRegulatory Compliance and Planning: Ensure processes are in place that support the Global Risk Register WG implementation of regulatory risk identification, tracking and mitigation steps to allow for greater optimization, and reporting to management.
(and others)
- 仕事内容
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Key Responsibilities：
The Global Compliance and Planning Manager will:
－Lead 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 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.
- 応募資格
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- 必須
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Position Requirements：
■Education
ーBachelor's degree (science discipline preferred). Further relevant qualification desirable.
ーAt least seven or more years’ experience in the pharmaceutical industry, with approximately 4 years that includes working knowledge of compliance activities within Regulatory affairs and Quality.
■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Office environment.
ーPosition requires approximately 10% domestic and international travel.
■Language skill:
ーProfessional English Proficiency
ーJapanese language skills are preferred
- フィットする人物像
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Key Competencies specific to the role
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.
[Essential requirement] Nonsmoker
- 雇用形態
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Full-time employee
*6 month trial period
- ポジション・役割
- Regulatory Affairs Dept., Global RA Compliance and Planning Group/ Staff or Manager
- 勤務地
- Head Office (Chiyoda-ku, Tokyo)
- 勤務時間
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A super flextime system: Working hours: 3-hours between 7:00 and 20:00 (no core time, working hours: 7 hours 40 minutes)
*Remote work available: Guideline: Coming to the office 1-3 days a week. Full remote work is not currently possible.)
- 年収・給与
- 6.5 million yen ～ 14 million yen (as guideline)
- 待遇・福利厚生
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Benefits: Social insurance (health insurance, nursing care insurance, employee pension insurance, employment insurance, workers' compensation insurance), various savings plans, residential sub-lending loan plan, 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 for marriage and childbirth, family support allowance, return employment system
*Smoking is completely prohibited in the company
*There are also systems for shortened working hours for childcare and shortened working hours for nursing care.
- 休日休暇
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Sundays, national holidays, Saturdays, New Year's holiday (12/29-1/3), 125 days off per year, 2 days off per week
Paid leave: 15-20 days depending on years of service
Other: Comprehensive systems for spousal maternity leave, maternity leave, and childcare leave.
- 選考プロセス
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Selection process:
Document screening ⇒ 1st interview ⇒ SPI aptitude test ⇒ Final interview (including English interview)
*Application document（CV) must be in English.
Generally, the interview will be held at the head office (Otemachi, Chiyoda-ku, Tokyo).
Travel expenses will be reimbursed.
*If you come by personal car, you will not be reimbursed.
*For the time being, online interviews may be conducted.
Note:
[Clarification in accordance with the amendment to the Enforcement Regulations of the Employment Security Law (effective April 1, 2024)]
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).
