Sr Specialist, Regulatory Affairs

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.

Essential Duties and Responsibilities. 

• Create and review regulatory documentation for Drug, Device and Combination product renewals and other life cycle maintenance-related submissions.
• Interact with non-regulatory support groups (i.e., manufacturing, product stability, quality, clinical, etc.) to request documentation necessary to support product renewals & submissions
• Track status and progress of regulatory documentation
• Coordinate and compile responses to regulatory authority questions (under supervision)
• Use an electronic document management system to compile documents to support submissions to Health Authorities
• Answer internal queries for assigned products
• Maintain Database of Regulatory Requirements for renewals
• Support other regulatory processes as required, including device establishment registration, drug listing, structured product labeling, and processing requests for certificates and legalization.

Qualifications. 

• Knowledge of regulations
• Scientific knowledge
• Administrative and project management skills
• Ability to contribute to multiple projects from a regulatory affairs perspective
• Ability to multitask and prioritize
• Interpersonal and communication skills
• Technical system skills (e.g. word processing, spreadsheets, databases, online research)
• Proofreading and editing skills
• Ability to independently identify compliance risks and resolve or escalate as necessary

Education and/or Experience. 

6 + years of regulatory experience within a healthcare environment.

Bachelor’s degree or country equivalent in a relevant scientific discipline.
Suitable candidates with a non-scientific degree may be accepted and undertake further training e.g. under an apprenticeship or similar post graduate qualification.

Reasonable Accommodations

Baxter 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.

Recruitment Fraud Notice

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