From development to application and approval throughout product life cycle after approval. Prepare regulatory application documents regarding test methods and any inquiries from health authorities.
* Investigate and analyze information on CMC requirements for Japanese approval applications
* Account product change in CMC related functions in determining product specifications
* Using PMDA consultation to strategize effective plan to develop CMC strategy
* Create notification materials and support cross functioning departments to ...
Plan and execute regulatory strategies to obtain worldwide approval. Lead negotiations with health authorities.
* Plan and execute regulatory strategies of new/existing products to obtain regulatory approval
* Communicate and negotiate with regulatory health authorities including PMDA
* Lead the preparation for JNDA submission and collaborate with global stakeholders to be in line with Japanese regulatory strategies
* Provide effective risk management plan
* Collaborate with cross functioning teams to be the point of contact i ...
Obtain licenses of products accordance with Japanese laws and regulations. Comply with Japanese laws and regulations to ensure the creation of new business license.
* To obtain product approval and notification based on pharmaceutical and medical device law
* Updated approval and certification of already existing products
* Collaborate with manufacturers and related departments
* Develop key relationships with government health authorities
* Work with internal and external stakeholders to obtain approval
Proactively and effectively manage the company product lines and plans on registrations and documentation. Interact and communicate with regulatory authorities to ensure efficient regulatory approval and answer any queries.
* Be able to provide input on regulatory related issues and providing solutions in line with compliance and company plans
* Plan and execute effective product registration of company product
* Coordinating and strategies in the submission to regulatory authorities
* Keep up to date time line of pending approv ...