R&D Regulatory Affairs Sr. Scientist（開発薬事） Full-time

Job Title

Develop an efficient and high value-added Japan regulatory development strategy in line with global strategies

Responsible as a contact person with regulatory authorities (MHLW and PMDA, etc.)

Contribute to improving documents quality submitted by authorities through review on CTD, PMDA consultation documents, responses to inquiries, etc.

Coordination of preparation and submission of NDA, PMDA consultation, responses to inquiries, etc.

Collection and analysis of regulatory information on NDA etc. and sharing to relevant parties

Coordination including HQ when interacting authorities (30-days review, PMDA consultation, NDA submission, NDA review)

Required Qualifications

Experience working at a pharmaceutical company or company related to pharmaceutical development

Filing/Review experiences

Master of Life Sciences or above

Basic knowledge about pharmacy or medicine

English skill at a level capable of reading English literature and communicating by email with overseas

Communication skills

Desired Qualifications

Positive

Logical thinking

Initiative / action type

Knowledge of Pharmaceutical Affairs Regulations

Accountability, Adaptability, Communication, Complaint Management, Data Analysis, Economic Impact Analysis, Interpersonal Communication, Medicinal Chemistry, Negotiation, Parasitology, Pharmaceutical Management, Pharmaceutical Manufacturing, Pharmaceutical Process Engineering, Pharmaceutical Sciences, Pharmaceutical Technologies, Pharmacodynamics, Pharmacogenomics, Pharmacokinetics, Pharmacy Regulation, Process Improvements, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Experience