Regulatory Affairs Specialist

hace 4 semanas

Chile BAXTER A tiempo completo

**This is where you save and sustain lives**

At Baxter, we aredeeply connected by our mission. No matter your role at Baxter, yourwork makes a positive impact on people around the world. You'll feel asense of purpose throughout the organization, as we know our workimproves outcomes for millions of patients.

Baxter's productsand therapies are found in almost every hospital worldwide, in clinicsand in the home. For over 85 years, we have pioneered significantmedical innovations that transform healthcare.

Together, wecreate a place where we are happy, successful and inspire each other.This is where you can do your best work.

Join us at theintersection of saving and sustaining lives—where your purposeaccelerates our mission.

Get ready for the next step in yourprofessional career

**Your role at Baxter**:
Responsiblefor the definition and execution of Regulatory strategies for thecountries where its operations are carried out management., supportnew projects and ensure up-to-date maintenance of the productportfolio or marketing authorizations for Baxter BusinessUnits.

**What you'll be doing**:

- Responsible for thepreparation and submission of health records for new products,submission of variations, renewal and CCDS changes of existing healthrecords, and monitoring all procedures generated before the healthauthority.
- Monitoring of the dossier request according to theRegistry planning with GRA (Global Regulatory Affairs). For variationsand renewals of health records, you are responsible for working withGRA on the documentation requirements to be able to align with thesubmissions.
- In conjunction with the Director of RegulatoryAffairs, preparation and maintenance of the area's budget.
-Regulatory indicators: Maintenance of the regulatory area databases(RADB, RIM, Share point, etc.).
- Verify compliance with authorizedlabeling in the Health Records for imported and locally reconditionedproducts. Make changes to the gear when vital to stay in sync withwhat was approved in the health records. - Maintain and safeguardpharmaceutical product record files, ensuring their integrity andconfidentiality.
- Contact with the Ministry of Health,presentation, processing and monitoring of requirements emanating fromthe ISP - Training of all applicable local procedures and trainingassigned by BAXu.

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

to the PharmacovigilanceSystem. Responsible for Techno-vigilance and Pharmacovigilance beforethe ISP.

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

LI-GR1

**ReasonableAccommodations**

**Recruitment Fraud Notice**

Baxter hasdiscovered incidents of employment scams, where fraudulent partiespose as Baxter employees, recruiters, or other agents, and engage withonline job seekers in an attempt to steal personal and/or financialinformation. To learn how you can protect yourself, review ourRecruitment Fraud Notice.

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