Preclinical Regulatory, Manager

Tokyo - Japan

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Career Category

Regulatory

Job Description

Group Purpose

Facilitate patient access to Amgen products in Japan through executing the development and regulatory plans; providing strategic regulatory expertise; interfacing with agencies on regulators; aligning with key cross-functional partners; integrating into Amgens commercialization process and continuously improving our processes and developing our talent.

Job Summary

Execute local preclinical documentation (Investigators Brochure for J-CTN Briefing Document for PMDA consultation and CTD preparation for J-NDA) and RTQs from Japan Health Authorities with Global Translational Science and Preclinical Development and manage outside service providers

Bring local preclinical expertise to Japan Project Teams and Global Product Strategic Teams in Amgen

Key Activities

Ensure quality of contents and of Japanese translation of preclinical parts in CTD for J-NDA and IB for J-CTN

Input Japan-specific requirements for preclinical development to global members as a local expert

Prepare and respond to preclinical questions for CTD and IB from PMDA with global members

Interact with Japanese healthcare providers (PMDA academic organizations and National Institute of Health Science) to obtain acceptability of preclinical data for J-NDA of innovative medicines

Interact with Key Opinion Leaders and/or Principle Investigators to convey preclinical knowledge of candidates (more of a focus area in Japan than in the west)

Knowledge and Skills

Knowledge of preclinical science (toxicology pharmacology and/or drug metabolism)

Knowledge for documentation (preclinical writing) and the quality of IB and CTD

Knowledge of Preclinical regulations/guidelines (including GLP and ICH) in Japan

Preclinical (toxicology pharmacology and/or drug metabolism) experiences in research lab

Working in matrix environments as One Team

Communication skills

Negotiation skills to Japan Health Authorities

English conversation read and writing

Computers: Microsoft Outlook/ Word/ Excel/Power Point

Education & Experience (Basic)

Master or Doctorate degree and 10 years of directly related experience

Over total 5 years experiences with preclinical pharmacology toxicology and/or drug metabolism for supporting CTN and NDA submission in Japan

Over 5 years experiences in pharmaceutical industry

Education & Experience (Preferred)

Over 5 NDA submissions and approvals in Japan (more preferred biologic experience)

Required Experience:

Manager

Career CategoryRegulatoryJob DescriptionGroup PurposeFacilitate patient access to Amgen products in Japan through executing the development and regulatory plans; providing strategic regulatory expertise; interfacing with agencies on regulators; aligning with key cross-functional partners; integratin...