Develop and execute regulatory affairs (RA) activities from the development to the life cycle management, with collaborative with global and Japan stakeholders.
Key Responsibilities:
Lead regulatory affairs interactions with Health Authorities (HAs)
Oversee New Drug Application (NDA) and supplemental NDA (sNDA) submissions
Manage Japan NDA preparation and support Health Authority review for approval
Prepare regulatory components of the Japan CTD, including the Approval Application Form and Module 1
Lead the development and maintenance of electronic Japanese Package Inserts (J-PI)
Serve as the Regulatory Affairs representative for SOP/Work Instruction updates and process improvement initiatives
| 職務経験 | 3年以上 |
| キャリアレベル | 中途経験者レベル |
| 英語レベル | ビジネス会話レベル |
| 日本語レベル | ネイティブ |
| 最終学歴 | 大学卒： 学士号 |
| 現在のビザ | 日本での就労許可が必要です |
Experience in Research & Development, particularly in Regulatory Affairs
Proven track record of collaboration with cross-functional teams and global stakeholders
Native-level Japanese and Advanced English
Strong stakeholder management skills
正社員
給与800万円 ~ 1500万円
業種医薬品
大手企業 (300名を超える従業員数) - 外資系企業
A local manufacturer is seeking Distribution Operators for its Niagara facility. The successful candidates will perform various warehouse duties and all procedures associated with unloading for truck and rail car operations, and shipping/receiving duties as required throughout...
...The primary purpose of your job is to assist with the delivery of patient care in accordance... ...language. * Successful completion of Medical Assistant School/Program. EXPERIENCE... ...the last 3 years preferred. Experience in Pediatrics is strongly preferred. LICENSURE AND/OR...
Description: The ideal profile for this role should include extensive experience in quality product management. Spcialiste de l'assurance qualit du matriel Note: le candidat idal aura des capacits bilingues. Dans le cas contraire, une exigence minimale est la...
...Lead intake for new event, venue, and show requirements. Provide timely responses to client requests and tight turnarounds. Assist... ...Coordination Support hiring, training, and coaching of full-time and part-time staff. Maintain schedules and assist with internal and...
...pipeline. ~ Based in Toronto, ON, with the ability and willingness to travel frequently to the U.S. ~ U.S. citizenship or valid U.S. work visa strongly preferred. ~ Bachelors degree in Business, Technology, or a related field (preferred). Why Join CBTW? Be a key...