Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.
We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.
Responsibilities:
- Prepare & submit documents, deliver timetable for license granted.
- Responsible for license maintenance including renewal, variation, PI, label etc.
- Responsible for FINA projects
- Responsible for registration affaires of exported product.
- Responsible for regulatory collection, analysis and implementation.
- Support site audit
- Responsible for variation assessment from plant (leverage Trackwise 8 when possible)
- Support other departments such as bidding, market, PV etc.
- Responsible for archiving registration dossiers(leverage BaxEdge or sharepoint)
- Responsible for other tasks assigned by supervisor above and support GRA CMC related tasks
- Develop and improve good relationship with the authorities and promote Baxter image.
Requirements:
- Bachelor degree in pharmaceutical, chemistry, biological and related discipline.
- At least 5 years working experience in a pharmaceutical company and at least 3 years pharm registration experience.
- Be able to project implementation, can face challenge
- Good communication skill, creative thinking, with teamwork spirit,
- Good at English writing, reading and speaking.
- Good Computer skill.
Reasonable Accommodation
Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link
Recruitment Fraud Notice
Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
