メディカル・バイオ - ＣＭＣ薬事

Make a strategic J-NDA plan for RA CMC and execute;
Deeply understand CMC requirements for J-NDA, especially for small molecules and/or biological products and evaluate the global CTD and conduct gap analysis.
Plan & execute CMC-related CTD preparation collaborating with QA and RA colleagues to keep J-NDA timeline.
Decide J-CTD (m3) policy related to CMC, draft J-CTD with global colleagues, and realize high-quality J-CTD.
Draft J-CTD (m2.3) based on J-CTD (m3), independently (for Senior Manager)/ under Senior or Group Manager supports (for Manager)
Explore appropriate strategic options and respond to Health Authorities’ inquiries interacting with global colleagues in consideration of approval matter.
Select and manage 3rd vendors related to CMC in order to ensure robust CMC activities.
Support & execute QA/RA activities if required.
Execute post-approval lifecycle management;
Evaluate the changes/deviations of manufacturing/analytical procedure which may affect approval matters for MCN/PCA.
Plan the MCN/PCA schedule and share it with QA/RA/global colleagues. Lead regulatory activity related to the change.
Manage appropriate CTD lifecycle and ensure the consistency between Master Batch Record/SOP, CTD (m3 and m2.3) and approval matter (m1.2).
Grasp the latest domestic and overseas technologies and regulations;

Understand the details of the actual manufacturing process and analytical procedures and create a CTD that is consistent with batch records and SOPs.

Be involved in project team meetings;
Understand the background of the product/formulation development and grasp its development schedule.
Sharing information with global teams when there are RA CMC-related requirements specific to Japan.

■休日：完全週休二日制, 土, 日, 祝日, 年末年始

・More than a bachelor’s degree, a pharmacist license is preferable.
・At least 5 years of pharmaceutical industry experience in RA CMC.
・At least 5 years of bio/synthesis/analytical/formulation laboratory and/or manufacturing experience.
・Experience in preparing M1.2 and 2.3 (small molecules and/or biological products) based on Global M3, Batch record, SOP, Validation report, and Stability report.
・English (business level).

■職種未経験者：不可