※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
[Position] Regulatory Affairs
[Salary] 8〜10 million JPY ※Experiences and skills will be considered
Regulatory Administrative Manager will support all Regulatory Affairs personnel in the our office and will oversee regulatory administrative related activities and document support related activities. This will include planning, scheduling, formatting, QC, PDF creation, transmitting, and paper and electronic archiving of regulatory submissions and archiving of all Health Authority communication and correspondence using company's controlled systems.
Manage timelines as required, and track status of submissions and project assignments; provide status updates, metrics, and other communications to Project Teams.
Participate in Regulatory teams as needed to ensure adequate follow-up Technical support; interface with Regulatory Operations as needed for support and guidance.
Maintain Japan specific submission templates and tools for generation of regulatory documentation.
Assemble processed regulatory documentation for submissions, including New Drug Applications, Prior Change Applications, Minor Change Notifications, and all Health Authority correspondence, including Q&A documents and written/oral communications.
As needed, prepare hardcopy documents, and prepare submissions, including photocopying, assembly, QC, and prepare for delivery, or transportation of hardcopy documents for clinical, CMC and labeling.
Support archiving of regulatory documents (paper and electronic) from interactions with MHLW / PMDA.
Support development of local processes for submission and document management in collaboration with Global regulatory process and local requirements.
Prepare electronic media, such as flexible discs (e.g. CD, DVD) as needed for submissions.
Support the Gateway administrator for JNDA submissions and FD application system for CMC / other business license submissions. and stay ahead of changes in regulatory guidance related to electronic submissions and systems.
Support business license maintenance activity such as MAH and Wholesale distributor (e.g. admin assistant; support management pharmacist to record and archive records for training kit of medical devices.
At least 3-5 years of experience in a regulated industry managing regulatory documentation.
Experience in the pharmaceutical field preferred.
Must be highly proficient in MS Office 2016 (with an emphasis on MS Word) and Adobe Acrobat (version XI Pro or DC preferred). Strong knowledge of eDMS such as VEEVA.
Knowledge of computer systems, electronic document management systems such as Veeva, and database management preferred.
Outstanding interpersonal and communication (written and verbal) skills is required.
Able to work in a matrix team environment, such as cross-functional groups in Regulatory Affairs, Clinical Development, Pharmacovigilence, etc.
Attention to detail and ability to manage multiple projects; Project management skills are a plus.
Native Japanese with proficiency in English language (reading and writing and preferably verbal).
Bachelor's degree in Pharmacy, Biology, Chemistry or related Sciences disciplines preferred.
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.
Seniority Level: Mid-Senior level
Job Function: Health Care Provider