Job Description

1. Basic Purpose of the Position
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* In order to develop veterinary biological products, conduct necessary studies and compile submission dossiers, including CMC part, (under the supervision of superiors, in case of Associate Scientist). In addition, expanding the value of existing product through line-extension is also within scope.
Responsible for the maintenance of existing veterinary biological products by conducting post-marketing surveillance and compiling submission dossier for re-examination, as well as managing minor/major change controls (under the supervision of superiors, in case of Associate Scientist).  
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2. Responsibilities
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* Establish development strategy and define the target product profile in Japan for veterinary biological products in collaboration with global counterparts and local business (under the supervision of superiors, in case of Associate Scientist).
* Execute and report GCP/GLP studies and GPSP surveillances for veterinary biological products in compliant with regulatory and internal requirements (under the supervision of superiors, in case of Associate Scientist).
* Compile submission dossiers for veterinary biological products for new marketing authorization, line-extension and re-examination (under the supervision of superiors, in case of Associate Scientist).
* Change control management for existing veterinary biological products by submitting minor/major variation changes to the authority (under the supervision of superiors, in case of Associate Scientist). This includes assessing planned change controls provided by global counterparts, preparing necessary data/documents for minor/major variation changes and collaborating with local and global colleagues.
* During the period of reviewing the submission dossier by the authority, prepare answers to the list of questions from the authority in collaboration with global colleagues (under the supervision of superiors, in case of Associate Scientist).
Represent the company at appropriate scientific meetings and relevant trade organizations ensuring alignment with company’s strategies and harmonization efforts (under the supervision of superiors, in case of Associate Scientist).  
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3. Required Education and Background
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* Bachelor’s degree in Life Science or related area (veterinary medicine, pharmaceutical science, etc.). Background with veterinary medicine will be preferred.
* Experience in animal health industry or pharmaceutical companies will be appreciated, but not mandatory.
Requires a minimum of 5 years of experience in clinical development and/or regulatory affairs as a Senior Scientist.  
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4. Required Skills
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* Sufficient Japanese level (N1), capable to prepare Japanese documents sufficient for the submission to the authorities, communicate various internal/external stakeholders and establish a favorable relationship.
* Business English in mid-level (TOEIC 700 and over), capable to communicate with various counterparts in global functions (reading, writing and speaking required).
* Basic knowledge of MS Word, Excel, Power Point and Teams.
* Skills in communication, facilitation and negotiation.
* Skills in scientific, strategic and logical thinking.
* Ability to work autonomous and result oriented.
* Thoroughness, commitment and fine attention to details.

Also required for the Senior Scientist:


* Project management skill (project management experience required).
Experience in process management (SOP creation/management).  
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5. Location
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Osaki Head Office (or work from home according to the labor regulations).  



6. Start Date
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As soon as possible (subject to negotiation)  



Recruiter : Nagai K