Specialist, Regulatory Affairs

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.

Essential Duties and Responsibilities:

This role resides within the Regulatory Operations - Systems and Submissions Operations organization. This function will partner with Global IT (GIT) and Global Regulatory Affairs (GRA)/Global Business Units (GBU) on the following:

• Management of Veeva RIMVault, PromoMats, CCDS, and other systems
• Processing license requests for Drug and Medical Devices in Veeva RIMVault system
• Supporting Data Governance of Veeva RIMVault system (Regulatory Information Management System) and PromoMats
• CCDS Coordination between Central CCDS team and Country Affiliates (to make sure timely submission of CCDS Updates to HA and CCDS Tracking Tool updates)
• Experience in accessing and retrieving documentation from electronic document management systems
• Will have to work independently with minimal support.
• Will be co-located with the current Regulatory Operations team in Bengaluru, India a minimum of 3 days per week.
• Will work with global regulatory leads (GRLs) across the Globe for Drugs and Devices
• Verify the maintenance of support systems, libraries, and dictionaries

Qualifications:

• Technical system skills (e.g. Excel spreadsheets, SharePoint, databases, online research)
• Strong written and verbal communication skills
• Knowledge of applicable regulations. Ability to understand and reduce to practice Global Regulatory regulations and guidelines, i.e. FDA and EU regulations, and ICH guidelines.
• Excellent organization skills and ability to support multiple projects
• Work independently with minimal direct supervision
• Ability to discuss technical matters with cross-functional team members
• Ability to independently identify compliance risks and resolve or escalate when necessary
• Experience in addressing complex problems or processes

Education and/or Experience:

• M-Pharm (Pharmaceutics)
• 4-6 years experience in Regulatory Affairs expertise, highly proficient in supporting and maintenance of Regulatory Information Management Systems (deep Veeva RIMVault and Veeva PromoMats) and other regulatory systems.

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

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