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Ra Manager, Regulatory Intelligence

4 months ago

Deerfield, United States BAXTER Full time

**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.**Your role at Baxter**:
**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

**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.

EEO is the Law
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**Reasonable Accommodations**

**Recruitment Fraud Notice**

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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