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.
Summary:
Responsible for the implementation of complex global regulatory strategies, obtaining and maintaining marketing authorizations for biologic products, and communication of general regulatory requirements in support of Pharma Partner products. Primary focus includes support of the Module 3/CMC submission sections.
Responsibilities:
Act as the Global Regulatory Lead for hemostat/sealant product(s) registered as biologic/combination
Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with Baxter and external standards
Assess impact of new regulations and provide feedback.
Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks
Provide technical and strategic input for regulatory decisions aligned with business strategy
Identify prioritize key areas of risk and probability of occurrence as well as ensure implementation of mitigation plans and follow ups
May act as primary contact for meetings with regulatory authorities including planning and leadership
Maintain appropriate communication within the RA function, with GBU Marketing, and with other functions primarily at the project team level
Plan and manage complex projects and prioritize workload
Initiate, manage and maintain operational activities in support of new and existing marketing authorizations
May manage regulatory budget at project level
May represent Baxter interests in industry and working groups
Set team, group, or service objectives to assure they align with the regulatory strategy
May provide direct supervision of individuals including mentoring, performance management and staffing decisions
Qualifications
Bachelor’s degree or country equivalent in a scientific discipline
Minimum of 5 years regulatory or equivalent experience within a pharmaceutical and/or medical device company, CRO, or similar organization.
Applications knowledge of biologics preferred
Experience with FDA regulations
Scientific knowledge
Ability to manage complex projects and timelines in a matrix team environment
Strong 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.
All prospective employees for this job will be required to verify that they have been fully vaccinated for COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law
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#IND-USOPS
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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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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