Principal 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.

Summary

Responsible for the implementation of complex global regulatory strategies, obtain and maintain

marketing authorizations for product(s) and communication of general regulatory requirements in

support of licensing of Baxter’s products. Serves as a consultant to managers. Manage regulatory

activities relating to specific global portfolio of products/projects. Initial focus of this role will be to support post-marketing regulatory activities for a specific portfolio of global products with emphasis on the coordination of regulatory impact assessments for post-marketing changes (change control) and subsequent variation preparation activities.

Essential Duties and Responsibilities

• Initiate and develop complex regulatory project plans

• Identify & prioritize key areas of regulatory risk

• Monitor applicable regulatory requirements

• Create and maintain regulatory files in a format consistent with requirements

• Provide regulatory advice to project teams.

• Respond to complex questions from regulatory authorities within strict timelines

• Compile and submit, in a timely manner, regulatory documents according to regulatory

requirements

• Maintain and update existing regulatory authorizations

• Manage regulatory activities relating to specific portfolio of products/projects

• Prepare, review, and approve labeling and SOP’s

• Lead or represent Regulatory Affairs in project teams

• Provide guidance and coaching for areas of responsibility to lower level team members

Qualifications

• Knowledge of regulations

• Scientific knowledge

• Project management skills

• Manage multiple projects and deadlines

• Ability to multitask and prioritize

• Interpersonal and communication skills

• Strong negotiation skills

• Technical system skills (e.g. word processing, spreadsheets, databases, online research)

• Ability to work effectively in multinational/multicultural environment

• Ability to identify compliance risks and escalate when necessary

Education and/or Experience

Bachelor’s degree or country equivalent in a scientific discipline

Minimum of 10 years regulatory or equivalent experience within a pharmaceutical and/or medical

device company, CRO, or similar organization

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.

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