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Senior Regulatory Affairs Specialist

4 months ago

Singapur, Singapore Baxter Full time

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

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

Participates 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