RA Manager, Regulatory Intelligence

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.

Your role at Baxter

Responsible and accountable for leading the design and development of global Regulatory processes & systems related to regulatory intelligence. Candidate will be responsible for all operational aspects of the Regulatory Intelligence program, including implementation of process and continuous improvement.

What you'll be doing

Act as RA Intelligence Team Lead responsible for the following:

• Analyze status quo (review existing procedures / vendors, and identify unmet representation needs in standardization committees)
• Customize and tailor future state process, including process design, vendor selection, and SOP development and deployment
• Establish appropriate communication within RA and with other functions primarily at project level and favor proactive communication
• May represent Baxter interests in industry and working groups
• Monitor applicable regulatory requirements; assure compliance with Baxter and external standards
• Identify & prioritize key areas of risk, and develop & implement appropriate mitigation plans
• Develop and implement role-based regulatory plans aligned with business needs
• Perform gap analysis on regulatory documentation and propose solutions. Identify areas for improvement
• Develop and document sound regulatory decisions and justification.
• Communicate with regulatory authorities
• Establish appropriate communication within RA and with other functions primarily at project level and favor proactive communication
• Lead role-based activities
• Represent or lead the RA function on assigned cross-functional project teams
• May provide direct supervision of individuals

What you'll bring

• Bachelor’s degree or country equivalent in a scientific field
• Masters and/or PhD will be an advantage.
• Minimum of 5-year regulatory experience in RA or related field, including people management or projects.
• Scientific knowledge
• Ability to multitask and prioritize
• Ability to work effectively in multinational/multicultural environment
• Sound basis of Regulatory knowledge
• Management skills
• Ability to manage complex projects and timelines in a matrix team environment
• Strong interpersonal, communication and presentation skills
• Demonstrated interpersonal skills including strong negotiation skills
• Technical and management skills
• Ability to lead and coach others
• Ability to independently identify compliance risks and escalate when necessary

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $104,000-$143,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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Pay Transparency Policy

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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