Regulatory Affairs Specialist, Pharma

Application deadline date has been passed for this Job.
Full-Time Employee
  • Post Date: 2019-08-27
  • Career Level Others
  • Offerd Salary ¥4 - ¥6 Million
  • Experience 2 Years
  • Number of employee 1
  • Gender Required Both
  • INDUSTRY Trade
  • Qualification Associate Degree
  • Working Hour 09: 00〜18: 00
  • Trial Period 3 months
  • Department Assign Production Materials Division Pharmaceutical Business Line R & D Team
Job Description

As a domestic manager (In-country caretaker (ICC)), I manage and maintain JDMF (Drag Master File). 

[Business description] 

– There are approximately 70 JDMF registered products for the drug substance we handle. As manufacturing methods are often changed at overseas manufacturing plants in order to improve manufacturing efficiency and reduce costs, overseas suppliers should regularly check for changes in manufacturing methods. 

・ Please update the contents of JDMF (Drag Master File) as necessary. 

If possible, take the role of a facilitator in dealing with the above series of overseas suppliers. 

・ About the contents related to JDMF (Drag Master File), such as providing information for customers in Japan.Consulting with overseas suppliers regarding the mechanism of JDMF (Drag Master File) in Japan and related laws and regulations 

・ JDMF implemented by PMDA (Drug Master File) Audit support 

・ As necessary, we have overseas suppliers (drug manufacturers), domestic customers (pharmaceutical manufacturers), and PMDA business trips / outside work. About 10-20%)



Hiring requirements

[Required requirements] 

・ Knowledge in any field of pharmacy, organic chemistry, analytical chemistry, physical chemistry 

 ( because our products are many chemical drugs) 

・ Business level English (with overseas suppliers) Necessary for communication. Basically, if you can read e-mails and documents.) 2 years of practical experience in the medical industry (pharmaceuticals, medical devices etc.) 

[welcome requirements] 

– Japanese pharmacopoeia, drug development, If you have knowledge of quality control, analysis methods, etc., it is better if you have experience working with drug substance manufacturers, drug substance trading companies, pharmaceuticals and bio-ventures.Peripheral knowledge including CMC affairs related to the above work, Experience 

・ Skills to imagine what is being done in a factory or laboratory using only documents, and to propose what you think is best using your own knowledge



Treatment conditions and salary bonus

4 to 6 million (monthly amount 280,000 to 500,000) (This is a model salary. Consideration is required after considering previous job, experience, and skills.) 

・ 86% of the annual salary presented 12 months as a fixed payment , Paid as a monthly salary. 

・ 14% of the annual salary presented The bonus will be paid in March of the following year as a performance-related bonus. (Linked to your department’s performance and personal evaluation)



Welfare

[ Welfare Program ] 

・ Social Insurance (Employment, Health, Work Accident, Employees’ Pension, Nursing Care) 

・ Membership Benefit Program 

 - Accommodation / Leisure / Sports / Entertainment / -Child Care / Care -Life Support / Disaster Compensation, Personal Injury Leave, Maternity / Maternity leave , long-term employee commendation system , retirement allowance system (either defined contribution pension (401K) or prepaid salary can be selected) , family (children) allowance , business trip allowance 

[training system] 

English and Chinese courses. We will respect the participation wishes such as financial statement training and manager training by foreign teachers as much as possible. If necessary, the company pays half of the cost of attending external training (limited amount), and it is a perfect environment for those who are willing to improve their skills without hesitation in self-investment.



Selection process

Document selection → Interviews 2 to 3 times ⇒Offer 

* Personnel interview ⇒Department manager interview ⇒ (Case-by-case, business confirmation interview with department staff) ⇒Offer



Holiday

2 days a week (Saturdays and Sundays), holidays, summer holidays, year-end and New Year holidays, annual paid holidays, Gyeongsang leave, sick leave

・ The working conditions, etc. specified in this job offer may differ from the working conditions at the time of signing the labor contract. 

・ This job offer includes information that has not been disclosed to the public, so it is prohibited to provide or forward it to third parties.