Take the lead in the company's IT systems in introducing/maintaining regulatory publishing information, budget management/LRP for the department. Vendor oversight as well as ensuring proper regulatory compliance for operations in Japan.
* Oversee in the management of publishing activities to be delivered according to regulatory submission plan based on Japanese requirements
* Align with global and local strategies in electronic submissions and conversions of eCTD applications
* Work with cross functional departments, global stak ...
Reporting to the Head of RA in Japan, lead in the RA strategy in labelling for company products. Provide any oversight in the Japanese market in regulatory development.
* Be part of the regulatory strategic decision making process for company's TA portfolio
* Partner with cross functioning departments to align product portfolio
* Communicate with external stakeholders to develop an effective local plan in the Japan market
* Take lead in the labelling assignments that can be accepted with Japan regulatory bodies and agencies
Take lead in regulatory strategies and development for company's products based on global and local regulations to obtain approval. Submit effective documents and negotiate with health authorities to fast track product approval for launch.
* Lead in the development of regulatory strategies and implementing scientific, business oriented, and dynamic knowledge in the development of products that requires regulatory approval
* Align local and global regulations and guidelines in implementing up to date regulatory strategies
* Creat ...
Regulatory Affairs is a unique opportunity that ensures proper compliance with applicable global laws and regulations in development to ensure commercialization of new drugs.
It offers extensive collaborations with other departments in a drug product lifecycle, ability to be part of the technical and business side, wide range of long-term career options/flexibility, and critical part to bringing drugs to save lives.
It is a role to be part of the drug applications for approval to obtain manufacturing/marketing approval from regula ...
Be responsible of the regulatory strategy and development for Japan in company's products and projects. Take lead in the regulatory team from the ground up.
* Develop RA strategies and development for products to obtain approval
* Take lead in communication as well as negotiation with PMDA consultation
* Work with global stakeholders as well as cross functioning departments to align local and global objectives
* Develop key essential documentations ex. CTN application, NDA submission and other approvals
* Ensure proper reg ...
Take lead in regulatory strategy and development for company products in Japan. Develop relationships with Japanese regulatory health authorities for approvals
* Represent Japan regulatory responsibilities for the global regulatory team of the organisation
* Develop and execute regulatory strategies for Japan that are also in line with global objectives
* Responsible of leading PMDA interactions and regulatory submissions
* Be the point of contact with regulatory insights for Japan