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Regulatory Affairs Specialist

hace 1 mes

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**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.

Get ready for the next step in your professional career

**Your role at Baxter**:
Responsible for the definition and execution of Regulatory strategies for the countries where its operations are carried out management., support new projects and ensure up-to-date maintenance of the product portfolio or marketing authorizations for Baxter Business Units.

**What you'll be doing**:

- Responsible for the preparation and submission of health records for new products, submission of variations, renewal and CCDS changes of existing health records, and monitoring all procedures generated before the health authority.
- Monitoring of the dossier request according to the Registry planning with GRA (Global Regulatory Affairs). For variations and renewals of health records, you are responsible for working with GRA on the documentation requirements to be able to align with the submissions.
- In conjunction with the Director of Regulatory Affairs, preparation and maintenance of the area's budget.
- Regulatory indicators: Maintenance of the regulatory area databases (RADB, RIM, Share point, etc.).
- Verify compliance with authorized labeling in the Health Records for imported and locally reconditioned products. Make changes to the gear when vital to stay in sync with what was approved in the health records. - Maintain and safeguard pharmaceutical product record files, ensuring their integrity and confidentiality.
- Contact with the Ministry of Health, presentation, processing and monitoring of requirements emanating from the ISP - Training of all applicable local procedures and training assigned by BAXu.

Responsible for advising the new regulations approved by the health authority, and in the case
- Support with regulatory information that is required for bidding processes.
- Collaborate and support with the information required by the MoH, during the inspections carried out

to the Pharmacovigilance System. Responsible for Techno-vigilance and Pharmacovigilance before the ISP.

**What you'll bring**
- Graduate in Pharmacy with a demonstrated ability in the regulatory area.
- Fluent English
- Previous experience in a Multinational industry, especially Chile and Argentina.

LI-GR1

**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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