Manager, Regulatory Affairs Operations

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.

What you will be doing:

• Managing the preparation of regulatory submissions for IND, ANDA, NDA, 510K, AdProm, and other electronic submission types

• Creating timelines for regulatory filings

• Providing and maintain templates for authoring.

• Overseeing authoring and reviewing of regulatory documents

• QC submission documents

• Managing external publishing teams supporting submissions in different markets (OUS).

• Managing Authoring support team working on electronic submissions.

• Contribute to the development of process improvements and procedural documents.

• Identifying and assessing regulatory risks and risks to timelines.

• Providing regulatory updates to the project team on different milestones.

• Working cross functionally with project management, operations, IT and other functions.

• Coordinate submission scheduling with regulatory publishing and ensures delivery of high-quality documents.

• Working closely with other members of the Regulatory team and provide support to their projects as needed.

• Maintaining archival of submissions and health authority communications in Veeva RIM system.

• Provide regulatory representation on key meetings, including meetings with health agency.

What do you bring:

• Solid understanding and experience and interpretation of regulatory requirements, with particular emphasis on the US region.

• Strong organization skills and the ability to track multiple timelines in parallel and manage deadlines.

• Excellent written and verbal communication and ability to collaborate across functions.

• Experience with Veeva Vault systems is preferred

• Strong team player, self-motivated and able to function independently as well as part of a team

• Able to work on multiple projects concurrently and adapt to a continuously changing environment.

• BA/BS in a scientific field and 5-7 years of proven experience

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 to support 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 $104,000 to $143,000 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.

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 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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