募集要項
- 募集背景
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Hiring background：Filling vacancies.
*One of the best companies in the pharmaceutical industry for work/life balance.
*Remote work is available: The company is promoting hybrid work, combining working from home and in the office.
- 仕事内容
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RA-CMC Global Approved Product LeadKey Responsibilities:
Accountable for RA-CMC activities for all globally approved products, leads team of SMEs and supports products directly, to:
- Create and develop global regulatory strategies for multiple products/projects, with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance and stable supply.
- Lead the preparation for, and conduct of, formal meetings with regulatory health authorities including the review of applications and negotiations with Health Authorities.
- Lead and drive global CMC submission activities (planning, authoring, reviewing, coordination, submission) for approved projects/products. Make quality regulatory decisions, balancing risks and benefits.
- Be the subject matter expert in JP post approval regualtions and requriements.
- Plan, prepare, and critically review CMC components of regulatory documents including Comparability Plans and Evaluation Packages, Meeting Briefing Packages, without supervision. Respond in a timely manner to deficiency questions and inquiries from health authorities. Collaborate with project team representatives to ensure those documents meet regulatory requirements/guidance.
- Communicate risks along with mitigation strategies to the project teams and management.
The appeal of this position：
Are you ready to lead the charge, managing the entire regulatory lifecycle of our diverse portfolio of groundbreaking products? You’ll have the exciting and unique opportunity to simultaneously work on Biologics, Small Molecules, and Drug/Device combinations, where your expertise impacts not just a company, but the future of healthcare.
Apply now and become a pivotal part of Our company’s innovative legacy.
- 応募資格
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- 必須
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Position Requirements：
[Required]
- Over 15 years of experience in the pharmaceutical industry, including at least 5 years in regulatory affairs.
- Experience as a Japan Regional CMC Regulatory Affairs representative for global products (biologics experience preferred).
- Experience in regulatory submissions to and post-approval interactions with JP Health Authorities (PMDA etc.), including handling inquiries.
- Proven experience collaborating with internal and external stakeholders, including global counterparts.
- People management experience.
[Preferred]
Experience in CMC regulatory affairs for the US, EU, or APAC regions.
Experience in preparing and managing the Quality (Q) part of regulatory submission documents.
■Language skill:
Japanese:Native-level Japanese proficiency
English：Capable of leading discussions and negotiations with global stakeholders in English
- 募集年齢(年齢制限理由)
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Up to 53 years old (40s welcome)
（定年年齢を上限として募集するため）
- フィットする人物像
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Key Competencies specific to the role:
- Excellent interpersonal and communication skills
- Demonstrated ability to collaborate effectively across diverse regions and cultures with a global perspective
- Proven capability to manage and lead multiple critical tasks concurrently
- In-depth understanding of CMC regulatory requirements and evolving scientific innovations
- Ability to proactively identify issues and risks based on available data and information, and to lead discussions with relevant stakeholders to develop strategies and countermeasures.
Our Group strives for Health ＆ Productivity Management aiming to “deliver good health, quality and well－being in each employee’s life.” We would like to request all the applicants for our mid－career recruitment to observe the following [Essential requirement]. We would appreciate your kind understanding.
[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
- Pharmaceutical Affairs Department/ AC-MC Group Lead (Line -manager)
- 勤務地
- Tokyo (Chiyoda-ku)
- 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 3 days a week.
- 年収・給与
- 11.2 million yen ～ 15.5 million yen
- 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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Document Screening* ⇒ First Interview ⇒ SPI Test ⇒ Final Interview
*Both Japanese and English CV are required.
Online interviews will be conducted.
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).
