Regulatory Documents Jobs in Japan

Job Description SummaryProvides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch premarket submissions/registrations and postmarket compliance working closely with healthcare regulatory bodies globally. Impacts quality of own...

SUMMARY:The Principal Medical Writer (PMW) is the accountable lead for his/her compound(s). The PMW works closely with Medical Directors Biostatisticians Regulatory Liaisons and others to develop high-quality clinical documents and is responsible for helping to drive document strategy development an...

BandLevel 4Job Description Summary-Contributes with appropriate oversight to all relevant aspects of global clinical trial(s) activities to deliver study outcomes within schedule budget quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member o...

Job Summary:To provide specialist regulatory knowledge and support for chemicals to ensure the regulatory compliance of these materials for both internal and external customers. Learning the requirement of and supporting the CSCL regulatory business.This role contributes to departmental revenue targ...

Summary of Responsibilities:Site management responsibility for clinical studies according to Fortreas Standard Operating Procedures ICH GCP Guidelines applicable project plans and Sponsor requirements including verification of study training records.Conducts site monitoring responsibilities for clin...

Position SummaryAssociate Director Regulatory Affairs is accountable for overall pharmaceutical affairs associated with development implementation and maintenance of regulatory strategies for assigned product(s)/project(s) in Japan with the intention of achieving successful registration and lifecycl...