Job opening - Group Manager - Regulatory Affairs in 東京23区 | Randstad

summary

東京23区, 東京都
¥11,000,000 - ¥13,000,000 per year, 年収1,100 ～ 1,300万円
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
Have a direct impact on improving patient health.
Inclusive and collaborative work environment.
Opportunities for professional and personal growth.

求められる経験
Skills & Experiences:
● Scientific (Chemical) or pharmaceutical background as well as regulatory knowledge (at least BA). Masters and/or PhD will be advantage. ...

● Experience of medical device registration (minimum 5 years).
● Experience of pharmaceutical drug filing (supportive activities would be acceptable).
● Management skills.
● Experience to prepare CTD Quality part (CMC RA)
● Demonstrated interpersonal skills including negotiation skills
● Ability to multitask and prioritize
● Establish relationship with regulatory authorities
● English skills: strong written, verbal communication and presentation skills (e.g., TOEIC: above 700 or 800)
● Experience worked for foreign companies is desirable

保険
健康保険　厚生年金保険　雇用保険,健康保険,厚生年金保険

休日休暇
土曜日　日曜日　祝日

給与
年収1,100 ～ 1,300万円

賞与
1300000

show more

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
Have a direct impact on improving patient health.
Inclusive and collaborative work environment.
Opportunities for professional and personal growth.

求められる経験
Skills & Experiences:
● Scientific (Chemical) or pharmaceutical background as well as regulatory knowledge (at least BA). Masters and/or PhD will be advantage.
● Experience of medical device registration (minimum 5 years).
● Experience of pharmaceutical drug filing (supportive activities would be acceptable).
● Management skills.
● Experience to prepare CTD Quality part (CMC RA)
● Demonstrated interpersonal skills including negotiation skills
● Ability to multitask and prioritize
● Establish relationship with regulatory authorities
● English skills: strong written, verbal communication and presentation skills (e.g., TOEIC: above 700 or 800)
● Experience worked for foreign companies is desirable

保険
健康保険　厚生年金保険　雇用保険,健康保険,厚生年金保険

休日休暇
土曜日　日曜日　祝日

給与
年収1,100 ～ 1,300万円

賞与
1300000

experience
Skills & Experiences: ● Scientific (Chemical) or pharmaceutical background as well as regulatory kno

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