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

summary

東京23区, 東京都
¥12,650,000 - ¥15,000,000 per year, 年収1,265 ～ 1,500万円
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
Lead regulatory strategies for a diverse portfolio of eye health products, including pharmaceuticals, medical devices, and over-the-counter solutions.
Play a crucial role in expanding market access in Japan for innovative eye care technologies that improve patients' quality of life. ...

Collaborate with a global team of experts in a company with over 170 years of history in advancing eye health and vision care.

求められる経験
Qualifications:
● Bachelor's degree (BA/BS) in a technical or scientific discipline such as biology, chemistry, physiology, pharmacology, engineering, medicine, or law
● Advanced degree or additional professional training preferred
● Pharmacist license desirable

Experience:
● 10+ years of experience in Regulatory Affairs within the healthcare industry
● Proven track record of successful submissions and approvals for pharmaceuticals, quasi-drugs, and medical devices (Class III or IV), including QMS submissions and/or foreign manufacturing registrations
● 5+ years of experience in recruiting, educating, and managing Regulatory Affairs team members in the healthcare sector
● Strong communication skills and ability to respond quickly and appropriately to Japanese authorities

Required skills:
● Strong leadership and accountability in the global healthcare business
● Hands-on experience with regulatory submissions, approvals, QMS submissions, and/or foreign manufacturing registrations
● Comprehensive knowledge of Japanese regulations, including PAL, ISO, IEC, and other related international regulations
● Scientific and clinical knowledge to understand technical documents and academic articles
● Analytical, problem-solving, and project management skills
● Excellent oral and written communication skills in both Japanese and English
● Business-level English proficiency (reading, writing, and verbal)

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,介護保険

休日休暇
土曜日　日曜日　祝日

給与
年収1,265 ～ 1,500万円

賞与
15%
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
Lead regulatory strategies for a diverse portfolio of eye health products, including pharmaceuticals, medical devices, and over-the-counter solutions.
Play a crucial role in expanding market access in Japan for innovative eye care technologies that improve patients' quality of life.
Collaborate with a global team of experts in a company with over 170 years of history in advancing eye health and vision care.

求められる経験
Qualifications:
● Bachelor's degree (BA/BS) in a technical or scientific discipline such as biology, chemistry, physiology, pharmacology, engineering, medicine, or law
● Advanced degree or additional professional training preferred
● Pharmacist license desirable

Experience:
● 10+ years of experience in Regulatory Affairs within the healthcare industry
● Proven track record of successful submissions and approvals for pharmaceuticals, quasi-drugs, and medical devices (Class III or IV), including QMS submissions and/or foreign manufacturing registrations
● 5+ years of experience in recruiting, educating, and managing Regulatory Affairs team members in the healthcare sector ...

● Strong communication skills and ability to respond quickly and appropriately to Japanese authorities

Required skills:
● Strong leadership and accountability in the global healthcare business
● Hands-on experience with regulatory submissions, approvals, QMS submissions, and/or foreign manufacturing registrations
● Comprehensive knowledge of Japanese regulations, including PAL, ISO, IEC, and other related international regulations
● Scientific and clinical knowledge to understand technical documents and academic articles
● Analytical, problem-solving, and project management skills
● Excellent oral and written communication skills in both Japanese and English
● Business-level English proficiency (reading, writing, and verbal)

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,介護保険

休日休暇
土曜日　日曜日　祝日

給与
年収1,265 ～ 1,500万円

賞与
15%
雇用期間
期間の定めなし

show more

experience
Qualifications: ● Bachelor's degree (BA/BS) in a technical or scientific discipline such as biology,

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posted 17 december 2024
社名社名非公開職種メディカルアフェアーズ、学術業務内容定年が65歳であり、雇用延長で65歳以上の方も働ける環境がございます少数精鋭の組織でありスピード感のある社内環境です複数のパイプラインがあり、プレローンチ活動から関わることができます求められる経験・PMS関連の経験3年以上・希少疾患領域でのグローバルレベルの経験があれば尚可・日本のPMS要件に関する理解および専門知識を有すること保険健康保険　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1,300 ～ 2,000万円賞与-雇用期間期間の定めなし
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health technology assessment manager at leading pharmaceutical company
- 東京23区, 東京都
- permanent
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社名社名非公開職種臨床開発、CRA、CRC業務内容Lead market access strategies and impact patient lives in Japan's dynamic healthcare market.■About the companyOur client is a global biopharmaceutical company committed to developing innovative therapies and improving patient lives. They have a strong presence in Japan and are seeking a highly skilled HEOR or HTA expert to join their team.■Role & ResponsibilitiesAs a Health Technology Assessment Manager, you will play a pivotal rol
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medical affairs manager (循環器領域)※組織の再構築に関わることができます※
- 東京23区, 東京都
- permanent
- ¥13,000,000 - ¥20,000,000 per year, 年収1,300 ～ 2,000万円
社名社名非公開職種メディカルアフェアーズ、学術業務内容定年が65歳であり、雇用延長で65歳以上の方も働ける環境がございます少数精鋭の組織でありスピード感のある社内環境です複数のパイプラインがあり、プレローンチ活動から関わることができます求められる経験・製薬業界にてメディカルアフェアーズの戦略に携わった経験が少なくとも5年以上・ビジネスレベルの英語力・循環器領域または希少疾患領域の経験　尚可保険健康保険　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1,300 ～ 2,000万円賞与-雇用期間期間の定めなし
posted 13 december 2024
社名社名非公開職種メディカルアフェアーズ、学術業務内容定年が65歳であり、雇用延長で65歳以上の方も働ける環境がございます少数精鋭の組織でありスピード感のある社内環境です複数のパイプラインがあり、プレローンチ活動から関わることができます求められる経験・製薬業界にてメディカルアフェアーズの戦略に携わった経験が少なくとも5年以上・ビジネスレベルの英語力・循環器領域または希少疾患領域の経験　尚可保険健康保険　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1,300 ～ 2,000万円賞与-雇用期間期間の定めなし
show job details

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