Especialista de Asuntos Regulatorios

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.

About Us: Baxter´s mission

Our products and therapies touch the lives of millions of people around the world every day, which is why we are passionate about ground-breaking innovations that brings more personalized care to all of us. For 87 years and counting, we have been at the critical intersection where the ideas that save and sustain lives meet the providers who make it all happen. And now, we are determined to realize our boldest opportunities to transform global healthcare for years to come.

Your role at Baxter

As a Regulatory Affairs Specialist, you will define and implement regulatory strategies to obtain new registration, variations and renewals for drug products and medical devices in the country assigned (Central America)

Your Team

We develop quality products with the patient in mind, so our efforts are also patient-centric. That means you can be proud of our work and the value we provide to people every day.

As a large, multinational organization, you have the opportunity to expand your knowledge through collaboration with a variety of individuals, exposure to different facets of our portfolio, and a supportive leadership team that encourages ongoing development.

This is where you save and sustain lives!!

What you'll be doing:

• Sanitary Registrations: Prepare and submit sanitary registrations for new products, including variations, renewals, and changes to the Core Company Data Sheet (CCDS) of existing registrations. Follow up on all procedures with health authorities.

• Dossier Management: Collaborate with the Global Regulatory Liaison (GRL) to manage documentation requirements for variations and renewals, and ensure compliance with submission timelines.

• Budget Management: Assist the Senior Manager of Regulatory Affairs in preparing and maintaining the regulatory budget.

• Regulatory Indicators: Maintain regulatory databases (e.g., RIM, SharePoint) to track compliance and performance metrics.

• Label Compliance: Ensure that labeling for locally imported and refurbished products aligns with authorized sanitary registrations, making necessary adjustments as needed.

• Record Management: Safeguard the integrity and confidentiality of pharmaceutical product records.

• Coordinate communication with Health Authorities, serving as a key contact for Ministry of Health and managing ISP requirements.

• Training and Compliance: Conduct training on local regulatory procedures and ensure the implementation of new regulations approved by health authorities.

• Support for Bidding Processes: Provide necessary regulatory information for bidding processes.

• Coordinate technovigilance and pharmacovigilance activities in compliance with ISP regulations in the country assigned

What you'll bring

• Bachelor's degree in Chemistry or related field

• Experience reviewing and approving promotional material and ensuring the obtaining of technical and legal documentation required for the approval and maintenance of the registrations of local and imported materials and products, and the preparation of the technical files by the current regulations for sanitary procedures and strategies developed for the Business Unit in Central America

• Support the definition of notifications to the regulatory agency of applicable FCAs and ensure the updating of the corporate databases of the Business Unit's products in Central America.

• Participate and support in the implementation of regional and global projects of the regulatory function.

• Support the reviewing of corporate policies and updating of PNOs related to the area, and participate in the review of the Health Legislation and advise the areas involved.

• Prepare reports with monthly indicators of the BU and deliver them to management and prepare Pharmacovigilance and Technovigilance charts and reports under current regulations and Align with the applicable CQP's.

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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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