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

summary

東京23区, 東京都
¥14,000,000 - ¥16,000,000 per year, 年収1,400 ～ 1,600万円
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
Join a global leader in the dental industry, offering a comprehensive lineup of dental aligner orthodontics and digital dental products.
Work in a rapidly growing market with opportunities for long-term stability and career growth. ...

Enjoy a flexible work environment, including the possibility of remote work, and a supportive company culture.

求められる経験
Qualifications:
● Strong communication skills to collaborate, coordinate, and negotiate with internal departments, global manufacturers, and regulatory authorities
● Problem-solving ability to address challenges
Leadership in identifying issues, planning, and executing solutions
● Graduated from university (Engineering or Chemistry preferred)
● No specific certifications/licensing required
● Over 7 years of experience in regulatory affairs in the medical device industry
● Experience with registering medical devices
● Qualified for marketing director of medical devices
● Safety management experience preferred
● Coaching skills to lead team members
● Native Japanese fluency, business-level English proficiency for communication with global stakeholders

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1,400 ～ 1,600万円

賞与
Variable
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
Join a global leader in the dental industry, offering a comprehensive lineup of dental aligner orthodontics and digital dental products.
Work in a rapidly growing market with opportunities for long-term stability and career growth.
Enjoy a flexible work environment, including the possibility of remote work, and a supportive company culture.

求められる経験
Qualifications:
● Strong communication skills to collaborate, coordinate, and negotiate with internal departments, global manufacturers, and regulatory authorities
● Problem-solving ability to address challenges
Leadership in identifying issues, planning, and executing solutions
● Graduated from university (Engineering or Chemistry preferred)
● No specific certifications/licensing required
● Over 7 years of experience in regulatory affairs in the medical device industry
● Experience with registering medical devices
● Qualified for marketing director of medical devices
● Safety management experience preferred
● Coaching skills to lead team members
● Native Japanese fluency, business-level English proficiency for communication with global stakeholders ...

show more

experience
Qualifications: ● Strong communication skills to collaborate, coordinate, and negotiate with interna

apply with randstad.
Applying with us is easy. We will review your application and see if you are a good fit for the job and the company.
we'll give you a call.
Our consultant will call you at a suitable time to discuss your application and further career aspirations.
getting you registered.
If you’ve never worked with us before, we’ll need some basic additional pieces of information to confirm your eligibility for work.
compliance check.
Next, we just need to verify a few things - we’ll make the relevant compliance checks and keep you posted.
reference and background check.
As part of the process in ensuring you’re perfect for the role, we’ll make contact with any relevant references you’ve provided.
the perfect job for you.
Our expert team will either arrange an interview for the role you’ve applied for, or if they believe there’s a better opportunity, they’ll suggest alternative options too.
the interview.
We’ll ensure that you’re fully prepared ahead of your interview and know exactly what to expect - good luck!
start your new job.
Congratulations, you’re ready to begin your new job. The team will ensure that you’re fully prepared for your first day.

senior manager, sales capability：製薬企業
- 東京23区, 東京都
- permanent
- ¥9,000,000 - ¥13,000,000 per year, 年収900 ～ 1,300万円
社名社名非公開職種営業(MR、MS、医療機器)、営業推進業務内容Develop and implement innovative training programs for a dynamic team in the pharmaceutical industry.■About the companyOur client is a leading pharmaceutical company dedicated to improving patient lives through cutting-edge treatments. They foster a collaborative and supportive environment, emphasizing continuous learning and professional growth.■Role & ResponsibilitiesIn this key role, you will design, develop, and deliver
posted 19 november 2024
社名社名非公開職種営業(MR、MS、医療機器)、営業推進業務内容Develop and implement innovative training programs for a dynamic team in the pharmaceutical industry.■About the companyOur client is a leading pharmaceutical company dedicated to improving patient lives through cutting-edge treatments. They foster a collaborative and supportive environment, emphasizing continuous learning and professional growth.■Role & ResponsibilitiesIn this key role, you will design, develop, and deliver
show job details
medical writing(senior specialist)：外資系製薬メーカー
- 東京23区, 東京都
- permanent
- ¥6,000,000 - ¥15,000,000 per year, 年収600 ～ 1,500万円
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・NDA関連文書を作成し、リードライターとしてその品質管理を行う。・医薬品規制、標準操作手順書（SOP）、マニュアルなどに従い、高品質なNDA関連文書を作成する。・メディカルライティンググループの代表として、担当プロジェクトチーム（JPT）の意思決定に貢献する。・規制当局からの質問への回答文書やブリーフィングブックなど、規制文書の作成を通じて担当JPTを支援する。・担当プロジェクトのNDA関連文書作成に関する方針、スケジュール、予算などの戦略を立案し、JPTに提案する。・NDA関連文書の開発および維持のための適切な手順を準備する。・グローバルメディカルライティングの関係者と協力関係を構築する。・ベンダー管理に関する適切な手順を準備および更新する。・ベンダーとの調整を行い、NDA関連文書の作成を支援する。求められる経験▼Senior SpecialistTOEIC700点以上臨床開発、薬事、市販後調査の経験（メディカルライティングの経験を含む）5年以上また
posted 19 november 2024
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・NDA関連文書を作成し、リードライターとしてその品質管理を行う。・医薬品規制、標準操作手順書（SOP）、マニュアルなどに従い、高品質なNDA関連文書を作成する。・メディカルライティンググループの代表として、担当プロジェクトチーム（JPT）の意思決定に貢献する。・規制当局からの質問への回答文書やブリーフィングブックなど、規制文書の作成を通じて担当JPTを支援する。・担当プロジェクトのNDA関連文書作成に関する方針、スケジュール、予算などの戦略を立案し、JPTに提案する。・NDA関連文書の開発および維持のための適切な手順を準備する。・グローバルメディカルライティングの関係者と協力関係を構築する。・ベンダー管理に関する適切な手順を準備および更新する。・ベンダーとの調整を行い、NDA関連文書の作成を支援する。求められる経験▼Senior SpecialistTOEIC700点以上臨床開発、薬事、市販後調査の経験（メディカルライティングの経験を含む）5年以上また
show job details
senior regulatory affairs manager
- 東京23区, 東京都
- permanent
- ¥10,000,000 - ¥15,000,000 per year, 年収1,000 ～ 1,500万円
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 with cutting-edge medical devices while playing a crucial role in bringing them to market through Japan's regulatory landscape, directly impacting patient care and medical advancement.The position offers an attractive work-life balance with flexible work arrangements (including remote work options)As a bilingual professional in this role, you'll collaborate with global stakeholders and local au
posted 18 november 2024
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 with cutting-edge medical devices while playing a crucial role in bringing them to market through Japan's regulatory landscape, directly impacting patient care and medical advancement.The position offers an attractive work-life balance with flexible work arrangements (including remote work options)As a bilingual professional in this role, you'll collaborate with global stakeholders and local au
show job details

Thank you for subscribing to your personalised job alerts.

You need to enable JavaScript to run this app.