Job Description

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. Draft, review and submit or support submission of Regulatory filings for Drugs and Medical devices (Re-registrations/ New Registrations/ Legal-Physical manufacturer transfer) for India/Sri Lanka/Bangladesh and Nepal Draft, review and submit or support submission of other Regulatory submissions for Drugs and Medical devices (Query responses, Corrections fillings, miscellaneous notifications regarding post registration regulatory lifecycle management) for India/Sri Lanka/Bangladesh and Nepal market in accordance with applicable regulations and relevant guidelines. Participates in the development and implementation of the regulatory strategy for drugs and medical devices Conducts regulatory monitoring of approved products by ensuring maintained files are current, ensuring regulatory compliance, evaluates the effects of an amendment or change and takes appropriate regulatory actions. Able to develop and implement appropriate regulatory strategies for the responsible countries to ensure business optimization. Monitor, track and provide project updates. Support, supervise and review team projects before submission to relevant authorities. To liaise with global regulatory team in obtaining materials for regulatory submission purposes, product related query from business and to address questions and issues which arise as part of registration. Participate and maintain working relationships and providing regulatory intelligence to relevant functional and business units team members. Support and assist supervisor in preparation of technical presentations/ meetings with the regulator and on various assigned tasks. Assist in preparation, review and maintenance of labels, SOP s, and other departmental documents. 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 .