Specialist, Global Regulatory Affairs

2 weeks ago

Deerfield, 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 with Baxter**

Responsible for implementing regulatory strategies, acquiring and maintaining marketing authorizations for Biologic and Combination Product(s) and presenting general regulatory requirements in support of licensing of Baxter’s Advanced Surgery products. Support a global portfolio of hemostat and sealant products/projects.

**What you will be doing**
- Support regulatory activities relating to specific portfolios of Biologic products/projects
- Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
- Maintain regulatory files in a format consistent with requirements
- Maintain and update existing regulatory authorizations
- With direction, develop and implement regulatory project plans
- Identify and elevate key areas of regulatory risk
- Respond to questions from regulatory authorities within strict timelines
- Maintain awareness of regulatory requirements; identify relevant requirements.
- Prepare, review, and approve labeling and SOP’s
- Participate as an active team member and provide regulatory advice to project teams as the need arises

**What do you bring**
- Bachelor’s degree or equivalent in a scientific field
- Knowledge of regulations
- Scientific knowledge
- Project management skills
- Lead 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 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._

**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**

**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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