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 ...
Be part of a global renown biopharma with rich development pipeline. Take lead in CMC RA activities to obtain regulatory approval.
Description
* Take lead in CMC RA activities for the business to obtain regulatory approval of new/existing products
* Prepare CTD documents (such as module 3) and other application form for submission
* Communicate with health authorities such as the PMDA for consultations and inquiries
* Collaborate with global stakeholders to align company strategies
* Ensure effective regulatory compliance requirements ...
Lead in new product launch submissions to obtain regulatory approval for Japan. Align company strategies to align with local regulations.
Description
* Take lead in RA activities for the business to obtain and maintain regulatory approval for company's products as a member of the global RA organization
* Work with cross functioning departments to align company strategy for the Japan market
* Prepare document submissions with company's time line
* Communicate with regulatory bodies and local health authorities
* Be part of the RA devel ...
Take lead in the RA department for new/existing applications/maintenance. Be part of the leadership team of the company.
Description
* Lead RA functions within the organization
* Be the key expert in Japanese regulations/guidelines
* register and maintain, new/existing products for the company
* Communicate with regulatory bodies to ensure proper results
* Collaborate with cross functioning departments/stakeholders to align regulatory strategies
* Be part of the Japan leadership team as well as communicate with global members
* I ...