Regulatory Certificate Specialist @ Regulatory Consulting

日本 外資系企業 年収 800万円 - 1000万円 外資系企業 View Job Description
Be part of one of the top global regulatory consulting companies in the industry. Take lead in applications for compliance inspections to obtain licensing.
  • Be part of one of the top global regulatory consulting companies in the industry
  • Take lead in applications for compliance inspections to obtain licensing

企業情報

  • Global Regulatory/Quality consulting company specialising in the pharmaceutical, medical device, cosmetic areas
  • Rich project pipeline working with some of the top health care companies in the industry to support in regulatory and quality activities
  • Japan business grew exponentially within the past 5 years due to demand
  • Fully remote
  • International environment with extensive global collaboration

職務内容

  • To process the application of the certificate of pharmaceutical product request to PMDA and the GMP compliance inspection application if necesary
  • Coordination with assigned stakeholders and CMO sites to obtain GMP certificate
  • To process the application of the GMP request to PMDA and the GMP compliance inspection application (if required)
  • Coordination with assigned stakeholders and CMO sites for timely obtaining of the manufacturing license certificate
  • To process the application of a manufacturing license request to PMDA
  • Receive the certificate from CMO sites or PMDA and process to the client
  • Prepare a dashboard for periodic communication indicating the key performance

理想の人材

  • University degree in scientific of related field
  • High fluency in English and Japanese (non-native level speakers will not be selected)
  • Knowledge of PMDA and MHLW submission experience for acquiring certificates
  • Pharmaceutical background

条件・待遇

  • Competitive salaries and benefits
  • Great work life balance
  • Fully remote option
  • Amazing career progression in RA pharma
  • Work with industry leaders who are solving various unmet medical needs
  • International working environment
コンタクト
Zach Itozu
求人番号
JN-042025-6708814
電話
+813 6832 8683

求人情報

分野
ライフサイエンス
職種
薬事・学術
業界
ヘルスケア・製薬
勤務地
日本
雇用形態
正社員
担当コンサルタント
Zach Itozu
担当コンサルタントの電話番号
+813 6832 8683
求人番号
JN-042025-6708814
企業タイプ
外資系企業

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