メルクと一緒に、あなたの力を発揮しよう
冒険、限界への挑戦、そして発見に焦がれるあなたへ。あなたの大志を、メルクで羽ばたかせましょう科学とテクノロジーを駆使したイノベーションに情熱を注ぐメルクのスタッフは世界中で活躍中です。ヘルスケア、生命科学、エレクトロニクスの分野で、メルクのソリューションは人々の暮らしをますます豊かなものにしています。あなたとメルクの力を合わせて、大きな夢を抱きましょう。メルクは、人、顧客、患者、そしてこの地球という惑星が共存する豊かな世界の構築に情熱を注いでいます。このためメルクでは、好奇心にあふれた人材を募集中です。メルクと一緒に、想像を超えた世界を開拓しませんか?
Job Description
Position:
Quality Regulatory Management
Regulatory Specialist
Responsibilities
Work in collaboration with Regulatory Experts to perform the following tasks:
- Preparation, submission, and maintenance of DMF (Drug Master File) for APIs and excipients, including communication with Marketing Authorization Holders
- Acting as an agent for Foreign Manufacturer Accreditation
- Maintenance of regulatory approvals for In Vitro Diagnostics (IVD) and Medical Devices
- Periodic review of application documents comparing Muster batch records.
- Arrangement for PMDA consultations
- Responding to GMP compliance inspections
- API Import license (Yakkan Shoumei)
- Monitoring regulatory changes and sharing updates with Global Regulatory Affairs
Requirements
- Licensed Pharmacist
- Comfortable with routine email communication in English
- Strong interpersonal skills and ability to collaborate across departments
Experience in regulatory submissions, quality assurance, or CMC within the healthcare industry is preferable.
Additional Information
- English proficiency is not mandatory but will be required for email correspondence with global teams
- Flexible work arrangement: up to 2 remote workdays per week
私たちが提供するもの:
私たちは、さまざまな背景、視点、人生経験を持つ好奇心旺盛な人々で構成されるグループです。この多様性が卓越性と革新を促進し、科学と技術のリーダーシップを強化すると信じています。私たちは、すべての人が自分のペースで成長し発展するためのアクセスと機会を創出することにコミットしています。何百万もの人々に影響を与え、誰もが人類の進歩を支持できるようにする包括性と帰属感のある文化を築くために私たちに参加してください
今すぐ応募して、発見を促し、人類の発展を高めることに専念するチームの一員になりましょう
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