Senior Regulatory Affairs Specialist
1 week ago
Vantive: A New Company Built On Our Legacy
Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. 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 are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.
*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.
Summary
This role provides regulatory support for new product development activities and post market support. The product portfolio consists of therapeutic products, biologics and medical devices. Responsibilities include preparing and implementing regulatory plans, supporting regulation changes and completion of regulatory deliverables. This includes managing local regulatory registrations with the global teams, impact assessments, new registrations, post-approval changes, and renewal, liaising with internal and external stakeholders in fulfillment of responsibilities. Must be a team player who can work independently and will take initiatives. To resume the responsibility as the company secondary responsible person. Well versed in pharmaceuticals and biologics regulatory landscape with at least 2 years of experience.Essential Duties and Responsibilities
Lead in the development and implementation of the regulatory strategy for therapeutic products and medical devices. Compile, prepare and submit new registration, variations, change notifications, renewals and ensure approvals in a timely manner. Ensure product labeling is in line with Company Core Data Sheet and country regulations. Learn, drive and manage various databases and reports ensuring information is accurate and up to date. Maintain regulatory files in a format consistent with requirements. 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. Work collaboratively with cross-functional team to ensure regulatory compliance and market continuity. Serve as key contact person for regulatory affairs and be the regulatory knowledge source for the cross-functional team. Communicate and, if necessary, negotiate with country Regulatory Agency to support key submissions/projects. Manage change controls and create strategies to support the execution and implementation of changes required by an initiative or project. Able to develop and implement appropriate regulatory strategies for the country to ensure business optimization. Participate and maintain working relationships and to provide regulatory intelligence to relevant functional and business unit's team members. Support the Function in driving RA operational excellence through strategizing and implementing local and/or regional continuous process improvement and/or digitization of procedures.Education and/or Experience
B-Pharm or B.Sc. in Pharmacy. Registered pharmacist with Singapore Pharmacy Council Well-versed with new registration, license extensions, variations and renewals. Additional experience with medical device registration is an advantage. 6 years of relevant experience in pharmaceutical and biologic industry-
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