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Sr Specialist, Regulatory Affairs

2 months ago

Round Lake, United States Baxter Full time

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
Sr Specialist, Regulatory Affairs is responsible for the coordination and preparation of regulatory documents/deliverables/packages to support Establishment Registrations and Listings for Drugs for the US market. May also support other standardized submission types and activities including Device Listings and Establishment Registrations as well as Certificates and Legalization. Development/maintenance of Regulatory trackers and databases. Evaluation and dissemination of new/changing regulations, guidance and standards.

What you'll be doing

* Pharmaceutical Drug Listing and Establishment Registration
* Review documents related to Structured Product Labeling/Drug Establishment Registration in association with Abbreviated New Drug Applications (ANDAs) and New Drug Applications (NDAs)
* Compile and submit, in a timely manner regulatory deliverables in support of Structured Product Labeling/Drug Establishment Registration submissions according to regulatory requirements
* Maintain regulatory deliverables in a format consistent with requirements
* Monitor and maintain awareness of regulatory requirements; identify and institute new/changing regulations, guidance and standards
* Participate as an active team member and provide regulatory advice to cross-functional project teams as required
* Respond to questions from regulatory authorities and internal stakeholders with urgency
* Maintain and update BaxEDGE-SPL (ALiCE) tool database and reports from said database
* May support regulatory activities relating to other standardized submission types as assigned, including Device Listings and Establishment Registrations as well as Certificates and Legalization
* Represent or lead Global Regulatory Affairs in small project teams

What you'll bring

* Bachelor's degree or country equivalent required.

* 3 years of relevant experience in regulatory affairs

* Knowledge of regulations
* 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 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 our employees, and we strive to be more transparent with our pay practices. To that end, this position has a salary range of $80,000 to $110,000 and also includes an annual incentive bonus. The above range represents the expected salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location.

Bachelor's Degree (16 years)

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 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.

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 and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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