Principal Specialist Regulatory Affairs

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.

Principal Specialist Regulatory Affairs

Essntial responsibilities:

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 Albania, Bosnia and Herzegovina, Serbia, Montenegro, Macedonia and  Kosovo.

• With direction, 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, all regulatory documents within RIM, according to regulatory requirements
• Maintain regulatory files in a format consistent with requirements
• Respond 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

• Prepare SOPs to reflect specific local requirements
• Establish appropriate communication within RA and with other functions, including distributors RA personnel to enable the clear understanding of requirements and the defence of Baxter positions when appropriate.
• Participate in procedures specifically related to release for country distribution and  labelling and advertising , including national language requirements.

Qualifications:

· Sound basis of regulatory knowledge
· Scientific knowledge
· Strong oral and written communication skills
· Demonstrated interpersonal skills including strong negotiation skills
· Ability to independently identify compliance risks and escalate when necessary

Computer skills
Basic knowledge required: Microsoft Office tools, interest in IT applications
Particular knowledge required: RIM if possible

Education and Experience:

Bachelor’s degree or country equivalent in a relevant scientific discipline (pharmacy, biochemistry, veterinary) with minimum of 5 - year regulatory or equivalent experience within a pharmaceutical and/or medical device company, CRO or similar organization.

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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