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 with Baxter
Under supervision responsible for implementing global regulatory strategies, acquiring and maintaining marketing authorizations for product(s) and communicating general regulatory requirements in support of licensing Baxter's products. Support regulatoryactivities relating to a specific portfolio of global products/projects.
What you will be doing
With direction, develop and implement regulatory project plans
Identify and elevate key areas of regulatory risk
Maintain regulatory files in a format consistent with requirements
Maintain awareness of regulatory requirements; identify relevant requirements
Participate as an active team member and provide regulatory advice to project teams as the need arises
Respond to questions from regulatory authorities within strict timelines
Compile and submit, in a timely manner, regulatory documents according to regulatoryrequirements
Maintain and update existing regulatory authorizations
Support regulatory activities relating to specific portfolio of products/projects
Prepare, review, and approve labeling and SOP's
Represent or lead Regulatory Affairs in small project teams
What do you bring
Bachelor's degree or country equivalent in a scientific field
Minimum of 2 years regulatory or equivalent experience within a pharmaceutical
Proven Knowledge of regulationsAffairs - CMC
Scientific knowledge
Project management skills
Manage multiple projects and deadlines
Ability to multitask and prioritize
Interpersonal and communication skills
Negotiation skills
Technical system skills (e.g., word processing, spreadsheets, databases, online research)
Ability to identify compliance risks and escalate when vital
Baxter is committed to supporting the need 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 $76,000 to $104,500 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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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.
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... For full info follow application link.
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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