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Regulatory Expert / Life Sciense

Position: Regulatory Expert

Location: Tokyo

 

The candidate will be a key regulatory expert for the portfolio of our Life Science business, pharmaceutical related products consisting of Medical Device, In-Vitro Diagnostic, API and excipient, single use, filter, consumable and process materials for the biopharmaceutical industry.
The ideal candidate should have an understanding of regulatory & quality for sterile drugs/biopharmaceuticals, including new drug registration, GMP and relevant regulations.

 

Key Job Responsibilities:
• Pharmaceutical and Medical Device Act related job.
• Pharmaceutical drug master file management.
• In-Vitro Diagnostic / Medical Device Marketing Authorization Holder license management.
• Pharmaceutical / In-Vitro Diagnostic / Medical Device Manufacture license (package, labeling, warehousing) management support.
• Foreign Manufacturers Accreditation/Registration management (Germany, Ireland, Switzerland and US).
• Corresponding with foreign manufacturers.
• Definition of processes to implement upcoming regulatory needs and requirements.
• Coordinates processes with internal functions for the commenting/drafting of regulatory/industry guidelines, regulations and standards.
• Monitor and report on changes of relevant regulatory and compliance environment with impact with Merck Life Science business. Analyze available regulatory and compliance information.
• Increases the influence of Merck in important regulatory bodies and industry associations.
• Secure flow of information from/to authorities, industry associations.
• Safeguard Merck LS strategic interests and objectives in arising guidance, standards and regulation.
• Training for and support of internal stakeholders and external customers.
• Take active role to build regulatory intelligence for Life Science. Focused area includes aseptic processing, sterile filtration, virus clearance validation, single use, process materials, chromatography, culture media.

 

Education and Languages required:
• Business level English skill (Must to have)
• Pharmacist (Must to have)

 

Professional Knowledge and Experiences (preferred):
• Knowledge of pharmaceutical related regulations and biomanufacturing.
• More than 10 years experiences in pharmaceutical related regulations and/or quality assurance in pharmaceutical company.
• Experience of Japanese Medical Device/In-Vitro Diagnostic QMS, GMP, ISO 13485 standards, regulatory and compliance requirements.
• Experience working in a global, matrix environment.

 

Personal Skills and Competencies:
• Ability to manage multiple priorities and deliver excellent outcomes.
• Good communication in multi- national cultures internally and externally.
• Capability on collaboration, communication and stress management
• Good project management skills.
• Ability to train and educate others.
• Good listening skills with the ability to analyze and respond to given situations quickly and effectively.
• Proficient in MS Office Software (Word, Excel, PowerPoint).

 

職務内容:
医薬品/医療機器等の法関連業務をご担当頂きます。

原薬、原薬マスターファイル管理
体外診断用医薬品/医療機器製造販売業管理
医薬品/体外診断用医薬品/医療機器製造業(包装・表示・保管)管理サポート

輸入先製造業者(ドイツ・アメリカ)からの情報入手及び交渉(読み書きレベルの英語が必要)

応募条件:

ビジネスレベル英語(必須)

薬剤師資格(必須)

バイオマニュファクチャリングもしくは医薬品の薬事知識もしくは経験(歓迎)
10年以上の薬事経験、または製薬会社での品質保証の経験(歓迎)

 

Recruiting contact: Fang Liu

 

 

Job Requisition ID:  195565
Location:  Tokyo
Career Level:  E - Professional (10+ years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


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