Principal Specialist, Regulatory Affairs - Pharmaceutical - Remote
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. Youll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxters 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 for the implementation of sophisticated global regulatory strategies, acquire and maintain marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of Baxters products. Serves as a consultant to managers. Manage regulatory activities relating to specific global portfolio of products/projects.
What you will be doing:
Initiate and develop sophisticated regulatory project plans Identify Supervise applicable regulatory requirements Build and maintain regulatory files in a format consistent with requirements Provide regulatory advice to project teams. Respond to sophisticated questions from regulatory authorities within strict timelines Compile and submit, in a timely manner, regulatory documents according to regulatory requirements Maintain and update existing regulatory authorizations Manage regulatory activities relating to specific portfolio of products/projects Prepare, review, and approve labeling and SOPs Lead or represent Regulatory Affairs in project teams Provide mentorship and coaching for areas of responsibility to lower level team members
What will you bring: Knowledge of regulations Scientific knowledge Project management skills Manage multiple projects and deadlines Ability to multitask and prioritize Interpersonal and communication skills Strong negotiation skills Technical system skills (e.g. word processing, spreadsheets, databases, online research) Ability to work optimally in multinational/multicultural environment Ability to identify compliance risks and escalate when necessary
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 $88,000 to $121,000 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.
#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. EEO is the Law EEO is the law - Poster Supplement Pay Transparency Policy
Reasonable AccommodationsBaxter 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.
Recruitment Fraud NoticeBaxter 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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