BRS Consultant
Patrick Chang
Pharma
Job number: JN -072024-141139
Posted: 2024-09-29
[Ascent] CMC RA
CMC RA
8 - 12 million yen
Tokyo
Pharmaceutical
Regulatory Affairs
Job details
- Company overview
- Newly started domestic CRO, rapidly expanding in APAC and focusing on smaller to mid sized pharmaceutical companies looking to enter Japan/APAC
- Responsibilities
-
- Prepare documentation (including for Cartagena Type 1 Applications and CMC Consultations) with team under direction of scientific/ management lead
- Interact and manage project communications with clients in bilingual environment
- Support interaction with regulatory authorities
- Requirements
-
- Experience with managing CMC issues within a pharmaceutical company or CRO
- Experience in animal cell research using genetic engineering
- Virology experience
- PhD or equivalently advanced level of research
- Business level English or above
- Salary
- 8 - 12 million yen
- Location
- Tokyo