Patent ・ Jobs in Japan search results

We are looking for quality assurance staff for a fabless manufacturer that does not have its own factories.

-Check whether the Good Manufacturing Practice (GMP) is being followed at overseas and domestic manufacturing factories

-Create a system to comply with the manufacturing practice and maintain Japan quality

-Check whether the necessary information is correctly written on the product label

-Create specifications based on information obtained from the manufacturing factory to ensure product quality (English and Japanese)

-Create manufac ...

Take lead in RA development strategy to obtain product approval. Work with the RA head to ensure PMDA submission of J-NDAs are aligned.


Description

* Take lead in RA development strategies/development
* Work with the RA head to ensure PMDA submission of J-NDAs are aligned
* As the RA lead work with other cross functioning departments to ensure company objectives are correct
* Develop key communication channels with the PMDA and other health authorities
* Be part of post-marketing RA responsibilities


Profile

* University degree ...

Be part of one of the top global regulatory consulting companies in the industry. Take lead in applications for compliance inspections to obtain licensing.


Description

* To process the application of the certificate of pharmaceutical product request to PMDA and the GMP compliance inspection application if necesary
* Coordination with assigned stakeholders and CMO sites to obtain GMP certificate
* To process the application of the GMP request to PMDA and the GMP compliance inspection application (if required)
* Coordination with assigned sta ...

Take lead in CMC RA activities for client needs on various projects. Lead the CMC RA Team.


Description

* Take lead in RA CMC strategy for company client's for various projects
* Lead the CMC RA department
* Develop CMC RA planning in terms of any change control activities, submissions, communication with the local health authorities (PMDA, MHLW) etc.
* Lead proper registration for client's facilties for FMA
* Execute regulatory strategies to align client's strategies
* Prepare in CTD documents to support in JNDA applications as well ...

Take lead in medical device RA activities for client needs on various projects. Act as a key consultant for class I-IV products for local regulations.


Description

* Support the planning and implementation for product registration in class I-IV products for the company's medical device clients
* Cover in various areas including in SaMD for end-to-end process of the product registration
* Be the SME for the business when it comes to RA area
* Ensure product registration translation work is correctly done
* Provide any local/regional reg ...

Be part of one of the top global rare disease company in the industry. Take lead in regulatory strategy/development to obtain product approval


Description

* Take lead in regulatory strategies/development to obtain product approval
* As a regulatory lead serve as a contact point for the business between local health authorities (PMDA)
* Communicate with global stakeholders to align company strategies from a regulatory point of view
* Prepare RA documents to develop product development plan
* Lead the submissions
* Liaison any local he ...