at Baxter Healthcare Corporation in Deerfield, Illinois, United States
Job Description
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:
The candidate will be directly responsible and accountable for global regulatory product ownership of pharmaceutical (drug) products. Responsible for establishing RA strategy for and authoring of US and EU dossiers (CTD M1 - M5), with heavy emphasis on Chemistry, Manufacturing, and Controls as well as drug product labeling. The person will be instrumental to the design and definition of the Regulatory strategy for the products in the business unit.
Essential Duties and Responsibilities:
* Develop and execute regulatory plans aligned with business strategy for complex projects including new products and maintenance of licenses/ authorizations for existing marketed products
* Author and lead preparation of submission deliverables and relevant CTD sections for US and EU drug product submissions, targeting first-pass approval from Health Authorities.
* Lead and support deliverable preparation / authoring for rest-of-world submissions for assigned drug product(s) for geographic expansion initiatives.
* Develop and document sound regulatory decisions and justification.
* Perform change control assessment consistent with global regulatory guidance
* Ensure global regulatory strategy and deliverables are aligned with project teams and business objectives
* Perform gap analysis on regulatory documentation and propose solutions. Identify areas for improvement
* Communicate with regulatory authorities
* Represent or lead the RA function on assigned cross-functional project teams
* Establish appropriate, proactive communication within RA, with GBU Marketing, and with other functions primarily at project level
* Identify & prioritize key areas of risk and develop & implement appropriate mitigation plans
* Monitor applicable regulatory requirements; assure compliance with Baxter and external standards
* May review SOP's for compliance with global regulations
* May represent Baxter interests in industry and working groups
Qualifications:
* Demonstrated success in previous US drug regulatory product lead role with strong experience in RA CMC / drug product labeling
* Scientific knowledge
* Ability to multitask and prioritize
* Ability to work effectively in multinational/multicultural environment
* Project Management skills
* Ability to manage complex projects and timelines in a matrix team environment
* Demonstrated interpersonal skills including strong negotiation skills
* Technical and management skills
* Ability to independently identify compliance risks and escalate when necessary
Education and/or Experience:
Bachelor's degree or country equivalent in a scientific discipline
Masters and/or PhD will be an advantage.
Minimum of 5-year drug regulatory experience in RA or related field, including managing people or projects.
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.
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 here and let us know the nature of your request along with your contact information.
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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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