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 ...
Take lead in regulatory submission activities for the business to get product approval. Be involved in publishing and archiving activities to ensure best practices.
Description
* Lead in regulatory operations in submissions and being informed of up to date regulatory information to manage tracking systems
* Be the main point of contact in electronic submissions, including new data requirements tracking regulatory data for RIM system
* Create eCTD documents and electronic JNDA Data to the PMDA and other health authorities
* Manage any reg ...
Be part of the RA department in leading regulatory submissions and approval for company's products in the Japan market. Lead in regulatory affairs strategies to align with global objectives.
Description
* Take lead in regulatory development/strategy for new drug applications to obtain approval
* Communicate with regulatory bodies and other local health authorities
* Ensure compliance with Japan standards to align company strategies
* Manage in project submissions in an appropriate manner
* Work with cross-functional departments to alig ...