Senior Manager, Global Regulatory Affairs

BAXTER

Deerfield, IL 60015

Posted 1 month ago

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

#LI-BAXGEN

#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 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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