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• 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
• 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.
|• 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.
We are Rakuten Medical, Inc., a privately funded, clinical stage, global Biopharmaceutical Company with locations in San Mateo, CA (Corporate Headquarters) and San Diego, CA (R&D Science Park), and regional offices in Japan, Taiwan, The Netherlands, and Germany.
We are supported by investors that have the commitment to build a fully integrated R&D and commercial biopharmaceutical company to innovate, develop, and commercialize cutting edge cancer therapies.
Currently are developing therapies based on a novel proprietary technology platform that utilizes antibodies conjugated with payloads that are specifically activated at the tumor site. Our first clinical product is in Phase 3 pivotal clinical testing 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. Given the rapid progression of the clinical studies we are quickly growing our teams to build and enhance in-house expertise with the intent to expand our R&D operations, clinical programs and prepare for the commercialization of our products.