Job opening - RA Director (Soukatsu) in 東京23区 | Randstad

summary

東京23区, 東京都
¥16,000,000 - ¥22,000,000 per year, 年収1,600 ～ 2,200万円
permanent

job category
biotechnology & pharmaceutical

job details

社名
社名非公開

職種
薬事、メディカルライティング

業務内容 ...

Mandatory1. General Marketing Compliance Officer (SOKATSU-SEKININSHA)Responsible to assure compliance with GVP and GQP through supervision and instruction to safety manager and quality assurance manager. Must report issues and risks to the MAH.・Is the contact person dealing with the authorities for RA in Japan.・Checks the legal and regulatory compliance as well as the scientific content of the documentation sent by the Corporate RA department. ・Submits variations, renewals or new marketing authorization applications to competent authority. Attaches any relevant documentation according to the local requirements. ・Is in charge of the follow-up of the pending approvals. Answers questions and provides additional documentation when requested by the authority. Informs the Corporate RA department about the approval status of the dossiers. ・Is in charge of the local regulatory intelligence. Informs the Corporate RA department about new regulations in Japan.・Proposes regulatory strategies based on expertise and knowledge of the Japanese laws about medicines.・Revises and validates the texts of the packaging materials and SmPCs of the products.

求められる経験
Pharmacist license in Japan. (mandatory as stiplulated by law)
3 years working experience related to GQP/GVP in Class 1 Pharmaceutical Company
Extensive knowledge of GVP and GQP for prescription drugs
Fluent in Japanese.
Business Level English (TOEIC>800).

保険
健康保険　厚生年金保険　雇用保険,労災保険

休日休暇
日曜日,土曜日,祝日

給与
年収1,600 ～ 2,200万円

賞与
-

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社名
社名非公開

職種
薬事、メディカルライティング

業務内容
Mandatory1. General Marketing Compliance Officer (SOKATSU-SEKININSHA)Responsible to assure compliance with GVP and GQP through supervision and instruction to safety manager and quality assurance manager. Must report issues and risks to the MAH.・Is the contact person dealing with the authorities for RA in Japan.・Checks the legal and regulatory compliance as well as the scientific content of the documentation sent by the Corporate RA department. ・Submits variations, renewals or new marketing authorization applications to competent authority. Attaches any relevant documentation according to the local requirements. ・Is in charge of the follow-up of the pending approvals. Answers questions and provides additional documentation when requested by the authority. Informs the Corporate RA department about the approval status of the dossiers. ・Is in charge of the local regulatory intelligence. Informs the Corporate RA department about new regulations in Japan.・Proposes regulatory strategies based on expertise and knowledge of the Japanese laws about medicines.・Revises and validates the texts of the packaging materials and SmPCs of the products. ...

求められる経験
Pharmacist license in Japan. (mandatory as stiplulated by law)
3 years working experience related to GQP/GVP in Class 1 Pharmaceutical Company
Extensive knowledge of GVP and GQP for prescription drugs
Fluent in Japanese.
Business Level English (TOEIC>800).

保険
健康保険　厚生年金保険　雇用保険,労災保険

休日休暇
日曜日,土曜日,祝日

給与
年収1,600 ～ 2,200万円

賞与
-

show more

experience
Pharmacist license in Japan. (mandatory as stiplulated by law) 3 years working experience related to

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