[Janssen] R&D Japan, Manager or Sr. Specialist/ CMC Marketed Products Group

Johnson & Johnson (Chiyoda, 日本) 5日前

POSITION SUMMARY:

-Responsible for overall CMC regulatory activities related to post-approval product change control in collaboration with Global and Japanese stakeholders.

-Create dossier for post-approval CMC regulatory activities in conformity to Japanese regulations for ensuring E2E CMC regulatory compliance, timely and strategically with science and logic-based approach.

-Propose CMC regulatory strategy for post-approval products change control.

-Creates CMC dossiers for the partial change application or Minor Change Notification of post-approval products strategically and keeping consistency/alignment throughout the documents.

-Prepares and answers to CMC questions from PMDA and communicate directly with PMDA officials where necessary.

-Handles change control of post-approval products and conduct CMC regulatory activities timely and strategically.

-Handles GMP inspection for the partial change application by PMDA.

-Handles J-DMF registration and change control.

-Maintains CMC document.


Qualifications

Required:

Experience: More than 5-years experience of CMC Regulatory Affairs or CMC research.

Knowledge: Basic knowledge of CMC Regulatory Affairs.

Education Level: Masters degree or Equivalent

Language: Fluent Japanese & business level English required (Writing/Reading/Speaking)

TOEIC score: 750 or above

Preferred:

Experience: Multiple CTD or NDA document creation experience.

Knowledge: Basic knowledge of CMC Regulatory Affairs.


Primary Location
Japan-Tokyo-To-Chiyoda-
Organization
Janssen Pharmaceutical K.K. (7195)
Job Function
R&D
Requisition ID
2105905570W

[Janssen] R&D Japan, Manager or Sr. Specialist/ CMC Marketed Products Group

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