Specialist, Regulatory Affairs

Specialist, Regulatory Affairs

The Pharmaceutical Affairs and Safety Management Department is mainly responsible for the pharmaceutical affairs and safety of commercial products, and the Pharmaceutical Affairs Liaison is responsible for all pharmaceutical affairs, including communication with the authorities and the global headquarters.

Since it is a new company, we will start and create an organization from now on. We are looking for people who enjoy creating new paths, who can think and act for themselves, and who can collaborate with other members. In the future, we will be able to expand the scope of our work by challenging inexperienced work such as new drug development.

Job content:

■　Maintenance / renewal of business license (pharmaceutical manufacturing and sales license), other pharmaceutical business

■　Operation / management of in-house (global) pharmaceutical business management system (document creation, management, etc.)

■ Management of in- house procedure manual (Global SOP and regulations) Management of procedure manuals in accordance with the above)

■ Revision and management of package inserts, etc.

Prerequisite:

■ Life science undergraduate graduate or above

■　Knowledge / experience regarding drug system / package insert (4 years or more)

■ IT system-related knowledge and skills

■ Knowledge regarding business-related regulations such as the Pharmaceutical Machinery Law

■ Business-level English proficiency (TOEIC 750) (Points and above)

■　Communication skills and cooperation that can build good relationships with others

■　New things, motivation to work on new tasks, positivity, flexibility

Desirable conditions, qualities:

■ Pharmacist qualification

■ SOP management experience related to pharmacy work

■　Project management skills that can take charge of multiple work and carry out work on time

■ New drug development experience

■　Attitude, sense of responsibility, courage to emphasize compliance Straightness

■ Logical thinking ■ Being

able to think and act for yourself