Job opening - Senior Specialist, Regulatory Affairs in 東京23区 | Randstad

summary

東京23区, 東京都
¥5,500,000 - ¥7,500,000 per year, 年収550 ～ 750万円
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
You'll have the opportunity to work on innovative healthcare products that make a meaningful impact on people's lives.
The role offers a collaborative environment with a team of experienced professionals dedicated to maintaining the highest regulatory standards. ...

You'll enjoy professional growth through continuous learning and exposure to complex regulatory challenges in a dynamic industry.

求められる経験
Qualifications:
● BA/BS degree in a technical or scientific discipline such as biology, chemistry, physiology, pharmacology, engineering, medical or law. Advanced degree or additional professional training is preferred.
● A Pharmacist license is desirable.

Experience:
● 7+ year experience as Regulatory Affairs in healthcare business. Successful submissions & approvals experience of pharmaceuticals, quasi drugs, medical devices, QMS submission, and/ or foreign manufacturing registration.

Required skills:
● Leadership and accountability
● Japan regulation knowledge management, not only PAL but also ISO, IEC, and other related international regulations etc.
● Scientific and clinical knowledge management to understand technical documents and academic articles, etc.
● Project management skills.
● Good oral and written communication skill (Both Japanese and English)
● Business English Level in writing and verbal

保険
健康保険　厚生年金保険　雇用保険

休日休暇
土曜日　日曜日　祝日

給与
年収550 ～ 750万円

賞与
支給あり
雇用期間
期間の定めなし

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
You'll have the opportunity to work on innovative healthcare products that make a meaningful impact on people's lives.
The role offers a collaborative environment with a team of experienced professionals dedicated to maintaining the highest regulatory standards.
You'll enjoy professional growth through continuous learning and exposure to complex regulatory challenges in a dynamic industry.

求められる経験
Qualifications:
● BA/BS degree in a technical or scientific discipline such as biology, chemistry, physiology, pharmacology, engineering, medical or law. Advanced degree or additional professional training is preferred.
● A Pharmacist license is desirable.

Experience:
● 7+ year experience as Regulatory Affairs in healthcare business. Successful submissions & approvals experience of pharmaceuticals, quasi drugs, medical devices, QMS submission, and/ or foreign manufacturing registration.

Required skills:
● Leadership and accountability
● Japan regulation knowledge management, not only PAL but also ISO, IEC, and other related international regulations etc. ...

● Scientific and clinical knowledge management to understand technical documents and academic articles, etc.
● Project management skills.
● Good oral and written communication skill (Both Japanese and English)
● Business English Level in writing and verbal

保険
健康保険　厚生年金保険　雇用保険

休日休暇
土曜日　日曜日　祝日

給与
年収550 ～ 750万円

賞与
支給あり
雇用期間
期間の定めなし

show more

experience
Qualifications: ● BA/BS degree in a technical or scientific discipline such as biology, chemistry, p

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