Job Description
Responsible for all activities of Japan regulatory operations as a lead of regulatory operation in collaboration with Global RA, Japan R&D, and other functional areas within Biogen.
Manage and maintain regulatory operational activities in drug development, NDA filing, NDA review, and post marketing stages (e.g., CTN, NDA/sNDA, JPI) in Japan based on the depth knowledge on Japanese regulation.
Develop and maintain procedures necessary to perform JRA activities in compliance with regulatory affairs and global policy/SOP
Support to maintain marketing business licenses in Japan according to the regulation
Key Responsibilities:
- Lead regulatory operation activities in Japan in collaboration with global and relevant functions.
- Identify appropriate resources/strategies needed to deliver on schedule with high quality.
- Responsible for regulatory submissions such as CTN, CTN amendment, and eCTD
- Document management within JRA, communicating with global RA
- Manage and maintain Japan labeling for all products according to global procedure and company core data sheet. Responsible for proper JPI format and consistency within Biogen products.
- Manage and coordinate venders to prepare necessary documents for submission to meet the timeline
- Support to maintain marketing business licenses in Japan according to the regulation
- People management of Senior associate and temporary staff
Qualifications
Essential Skills and Qualifications Required:
- Has sufficient knowledge and understanding of pharmaceutical regulations and is able to grasp the latest pharmaceutical regulations at all times.
- Ability to accurately interpret regulations and appropriately execute pharmaceutical dutiesCommunicate appropriately with various stakeholders to achieve goals
- Drive regulatory operation team
- Advanced knowledge of global/local system related to regulatory affairs, such as e-submission, change control.
- Extensive knowledge of handling Japan labeling creation including communication with PMDA and ability to assess appropriateness and consistencies among JPIs and CCDS.
- High fluency in English (business level) and Japanese
Education:
- BA/BS/University degree required; Life/Health Sciences preferred.
Experience:
- 5 years+ biotechnology or pharmaceutical experience
- 3-5 years’ experience in regulatory affairs or equivalent experience/education
- Good knowledge and understanding of regulations.
- Ability to interpret regulation
Additional Information
Why Biogen?
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts
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