Regulatory Affairs Officer (Japanese Pharmaceutical Company)

at  KOWA PHARMACEUTICAL ASIA PTE LTD

Suggestion of the strategy of business plan in view of R&D.
Planning clinical studies of pharmaceutical products
Submissions of Investigational New Drug (IND) applications, and New Drug Applications (NDA) in Singapore and other ASEAN region (e.g. Singapore, Malaysia, Indonesia and Philippines)
Update information of regulations in our targeted countries and highlight that associated with our products.
Management of the accounting in the division.
Cooperate and communicate with members in sales & marketing departments, headquarter, other branches and relevant 3rd parties.
Report monthly activity to headquarter and periodically meetings with headquarter.
Basic qualifications and previous experience:
A minimum 10 years of experience in clinical development and/or regulatory management of pharmaceutical products.
High communication skills with stakeholders about regulations associated with IND, NDA, MAV (major variation) and MIV (minor variation).
High interpretation skills of regulations in each country such as HSA, DCA and others in our targeted countries.
English proficiency, both written and spoken.
Japanese proficiency, both written and spoken.
Preferably master degree in science and/or any relevant degree in pharmaceutical.
Interested candidates who wish to apply for the advertised position, please email us an updated copy of your resume.
We regret that only shortlisted candidates will be notified.
Email Address: venus@kowa.com.s

Please refer the Job description for details