Senior Specialist, Regulatory Affairs

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride. 

Person in the role will be responsible for the local implementation of regulatory strategies, obtaining and maintaining marketing authorizations for products and communication of local regulatory requirements in support of licensing of Baxter’s products. Supports regulatory activities relating to products/projects in Bosnia and Herzegovina, Serbia, Montenegro, Macedonia, Kosovo and Albania.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Develop and execute regulatory project plans
• Represent or lead Regulatory Affairs in small project teams
• Participate as an active team member and provide regulatory advice to project teams as required
• Identify & prioritize key areas of regulatory risk
• Maintain awareness of regulatory requirements; identify relevant requirements
• Compile and prepare for submission, in a timely manner, regulatory documents according to regulatory requirements
• Maintain regulatory files in a format consistent with requirements
• Support preparation of responses to questions from regulatory authorities within strict timelines
• Maintain and update existing regulatory authorizations
• Support regulatory activities relating to specific portfolio of products/projects
• Prepare, review, and approve labeling
• Review AdProm materials for compliance with local regulations

WHAT ARE WE LOOKING FOR:

• Regulatory Affairs Expertise – minimum 2 years of experience in pharma/medical devices/CRO; strong understanding of submissions, renewals, variations, and interactions with Health Authorities.
• Project Management – ability to plan, execute, and lead regulatory project activities across multiple countries.
• Risk Assessment & Compliance – skill in identifying regulatory risks and ensuring compliance with local requirements, including labeling and AdProm.
• Education - Bachelor’s degree or country equivalent in a relevant scientific discipline
• Documentation Accuracy – high attention to detail in preparing, submitting, and maintaining regulatory files and documentation.
• Analytical Thinking – capability to interpret guidelines, assess regulatory impact, and propose clear regulatory pathways.
• English language knowledge – strong written and verbal communication in English
• Communication skills - ability to clearly convey regulatory guidance, collaborate effectively with cross‑functional teams, and prepare precise regulatory documentation. Able advise cross‑functional teams effectively.
• Organizational & Time Management Skills – ability to manage multiple tasks and meet strict regulatory timelines consistently.

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 minimum salary for this position is 46 400,00 EUR Annually. Your initial pay could be at the minimum or higher based on skills and expertise, experience, and other relevant factors, all of which are subject to change. This position may also be eligible for competitive benefits, discretionary bonuses, and/or long-term incentive. 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

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.

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.

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