Work in Japan : Regulatory Affairs Associate Director

Minimum Experience Level

Over 6 years 

Minimum English Level

Daily Conversation 

Minimum Japanese Level

Fluent 

Minimum Education Level

Bachelor's Degree 

Visa Status

Japanese national or permission to work in Japan required  

An international prescription pharmaceutical medicine company is seeking a Regulatory Affairs Associate Director for their Tokyo branch. The Regulatory Affairs Associate Director will be responsible for regulatory filing and operation management. Responsibilities also include ensuring quality document, filing of each assigned project and getting approval.

・ Preparation of quality document packages required for IND amendments, Master files, and other regulatory submissions
・ Reviews submission related documents such as safety reports, clinical protocols, Investigator’s Brochure, SOPs, process descriptions, change controls to ensure compliance with authority guidelines
・ Assists in the development and maintenance of organizational systems for the department’s operational functions.
・ Strategy and schedule planning of filing
・ Negotiation with administrative agencies

The successful candidate will have a university degree or above, over 4 years of experience working as a regulatory affairs manager, as well as hands on experience in all aspects of preparation, submission, negotiation and getting approvals. Fluent level Japanese and intermediate English is also required for this role.

・ University degree or above
・ Over 4 years of experience working as a regulatory affairs manager
・ Hands on experience in all aspects of preparation, submission, negotiation and getting approvals.
・ Ability to communicate smoothly with other departments

・　　　　大学卒業以上
・　　　　４年以上の薬事部門のマネージャーとしての実務経験
・　　　　承認を得るための準備・提出・交渉のすべての面での経験
・　　　　流暢な日本語力と中級レベルの英語力

Way Simmons Partnership has offices in Tokyo, Hong Kong and Singapore and provides contingency, advertised and search solutions across the commerce and industry sector. Our recruitment business is categorised as specialist/professional. With many years of experience in search and selection our team of expert recruitment consultants has experience in the following areas:

Executive & Management
Accounting & Finance
Human Resources
Marketing & Sales
Executive Support

We act for Multinational Companies (MNCs), Small to Medium Enterprises (SMEs) and locally grown diversified businesses and employers of choice who understand the value of working in partnership with a totally focused approach to human resource solutions.

All our consultants are able to rapidly understand their clients’ hiring requirements whilst developing a strong relationship of trust with their candidates. Our team prides itself on carrying out their work with the utmost confidentially and integrity and for candidates, there is no charge for the services that we provide.

Way Simmons Partnership is a division of Legal Futures Japan K.K.

Our recruitment business is categorized as specialist/professional and our placements are limited to Japan only. Our service is free of charge. We will apply and follow the laws and principles of all relevant legislation and maintain data privacy at all times. Please refer to www.legalfutures.com to view our Privacy Policy. The person handling personal information is our license holder Matt Anderson who will also handle any complaints.