Preclinical Regulatory, Manager
Amgen(1 month ago)
About this role
Senior regulatory role supporting Amgen’s Japan development and commercialization efforts by executing local preclinical regulatory plans and documentation. The position focuses on preparing preclinical components of CTDs and IBs for J-NDA and J-CTN, managing interactions with Japanese health authorities and external service providers, and contributing local expertise to global project teams. It supports alignment across cross-functional partners to facilitate patient access to Amgen products in Japan.
Required Skills
- Preclinical Science
- Toxicology
- Pharmacology
- Drug Metabolism
- Preclinical Writing
- GLP
- ICH Guidelines
- Regulatory Affairs
- CTD Preparation
- IB Preparation
+3 more
Qualifications
- Master's Degree
- Doctorate Degree
About Amgen
amgen.comAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
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