Be part of a critical member in the RA organization. Lead in RA development/strategy activities to obtain product approval for various unmet medical needs.
Description
* Take lead in RA development/strategies to obtain local regulatory approval for company's products
* Collaborate with global stakeholders to align overall business objectives
* Lead in product filing, pre-submission necessities, PMDA consultations
* Support in informing the business in local guidelines/regulation requirements
* Communicate, negotiate, develop key relat ...
(Overseas candidates able to apply / visa sponsored )
As a patent engineer, he assists in the acquisition of rights in Japan and overseas. You will be mainly in charge of projects in the technical field of "electricity/software", but there is no problem if you are willing to learn even if you are good at other technical fields.
In addition, we may be able to provide support as necessary in operations such as prior art searches, FTO surveys, invalidity surveys, appraisals, and dispute resolution.
At this point, English ability is not required.
Lead in RA activities to obtain regulatory approval for company products. Expand the business into the Japanese market.
Description
* Lead in regulatory submissions for company products to obtain product approval
* Develop effective regulatory strategies and collaborate global stakeholders to align business growth
* Communicate, negotiate, develop key relationships with health authorities (PMDA, MHLW, etc.)
* Be the key person to share necessary regulations/compliance requirements in Japan
* Manage any regulatory changes, procedures, ...
Lead in RA activities to obtain regulatory approval for company products. Expand the business into the Japanese market.
Description
* Lead in regulatory submissions for company products to obtain product approval
* Develop effective regulatory strategies and collaborate global stakeholders to align business growth
* Communicate, negotiate, develop key relationships with health authorities (PMDA, MHLW, etc.)
* Be the key person to share necessary regulations/compliance requirements in Japan
* Manage any regulatory changes, procedures, ...
Take lead in diverse range of RA projects to support clients in obtaining regulatory approval. Provide expertise in RA strategy/development.
Description
* Lead in multiple RA projects to support clients in obtaining regulatory approval
* Provide expertise in RA development/strategy
* Create appropriate materials and provide consultancy advice to implement best practice
* Lead in business development to partner with new clients to increase business
* Share strategic advice for regulatory applications and communications with health auth ...