Principal 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. 

We are looking for a Principal Specialist, Regulatory Affairs to join our team in Malta. This role resides within the Regulatory Operations - Systems organization. This function will partner with Global IT (GIT) and Global Regulatory Affairs (GRA)/Global Business Segments to:

• Create strategy to identify changes to procedures/processes across Global Regulatory Affairs and ensure implementation of procedures and processes for the Global Regulatory function.
• Provide metrics to ensure compliance to requirements, identify gaps and escalate as needed.
• Lead and support PromoMats, RIM and other RA systems
• Participate in system upgrades to assure integrity of data is maintained. Run and revise UAT Test scripts partnering with GIT for the most efficient solutions.
• Verify the maintenance of support systems, libraries, and dictionaries.
• Maintain awareness of regulatory requirements and evaluate potential impact to Baxter.
• Lead and participate in system projects and process requests to maintain data accuracy
• Responsible for establishing data Governance for RA systems

Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.

• 3-5 years of experience in Regulatory Affairs, preferably within the MedTech or pharmaceutical industry
• Ability to work in RIM (Regulatory Information Management System)
• Technical system skills (e.g. word processing, spreadsheets, databases, online research)
• Experience with SharePoint 2010 and Excel will be an advantage.
• Strong written and verbal communication skills
• Knowledge of Veeva Systems
• Excellent organization skills and ability to support multiple projects
• Work independently with minimal direct supervision
• Strong negotiation and collaboration skills
• Ability to independently identify compliance risks and resolve or escalate when necessary
• Experience in addressing complex problems or processes

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 €36.800 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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