(Assistant)Manager, Regulatory Affairs
职缺描述
• Manage the activities of Regulatory Affairs within the field of responsibility, ensure the
implementation of appropriate and effective regulatory strategies.
• Coordinate submissions and approval of all Regulatory Affairs applications.
• Manage and oversee all relevant maintenance activities, primarily, Life Cycle Management strategy.
• Ensure the completion of post approval commitments.
• Ensure all submissions are compliant with regulations.
• Manage submissions and document storage processes.
• Keep up to date with changes in regulatory legislation and guidelines.
• Provide information about regulations to stakeholders.
• Ensure the deliverables meet the corporate regulatory and quality standards, as well as deadlines
set.
• Liaise and negotiate with regulatory authorities.
• Proficient in a variety of specialized computer applications relevant to Regulatory Affairs.
• Stay abreast of all regulations to ensure the compliance of documentation.
• Other duties as assigned.
职务需求
| • Appropriate educational qualification, at least college level. Pharmacy major is preferred. • Minimum of 4-6 years' experience in handling NDA Registration. • Good track record in RA implementation/tracking. • Possess detailed knowledge of Taiwan registration requirements, including the understanding of relevant legislation, guidelines and processes, locally and internationally. • Excellent organizational skills and ability to meet deadlines. • Exceptional self-management ability. |
关于我们
Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox™ technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site.
Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer.
Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 5 locations in 5 countries, Japan, the Netherlands, Taiwan, and Switzerland. For more information, visit www.rakuten-med.com.
