at Baxter Healthcare Corporation in Round Lake, Illinois, United States
Job Description
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.
Your Role at Baxter
Responsible and accountable for all global operational aspects of regulatory submissions providing planning and technical support for Baxter's products for a business unit. Instrumental on the design and definition of the Regulatory strategy for the products in the business unit.
What You'll be doing
Develop and execute regulatory plans aligned with business strategy for complex projects including new products and maintenance of licenses/ authorizations for existing marketed products
Identify & prioritize key areas of risk and develop & implement appropriate mitigation plans
Monitor applicable regulatory requirements; assure compliance with Baxter and external standards
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, with GBU Marketing, and with other functions primarily at project level and favor proactive communication
Ensure regulatory strategy and deliverables are aligned with project teams and business objectives
Lead regulatory activities related to their portfolio of products
May review SOP's for compliance with global regulations
Represent or lead the RA function on assigned cross-functional project teams
May represent Baxter interests in industry and working groups
May provide direct supervision of individuals
What you'll bring
Bachelor's degree or country equivalent in a scientific discipline
Masters and/or PhD will be an advantage.
Minimum of 5-year regulatory experience in RA or related field, including managing people or projects.
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
Ability to independently identify compliance risks and escalate when necessary
Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.
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 $112,000 to $154,000 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. This position may also be eligible for discretionary bonuses. 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.
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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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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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