Sr Analyst, Regulatory Affairs (Santiago)

Sr Analyst, Regulatory Affairs (Santiago)

07 sep
|
Vantive
|
Santiago

07 sep

Vantive

Santiago

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Your Role





Support regulatory submission processes and maintenance of Marketing Authorizations for the assigned LAS cluster countries: Chile, Argentina, Paraguay, Uruguay, and Bolivia. Ensure that the labeling of assigned products complies with regulatory requirements. Actively participate in change control processes. Guarantee the timely update of regulatory databases.

What you’ll be doing

1. Support the submission of regulatory dossiers assigned for new product launches or for the maintenance of marketing authorizations (renewals, variations).

2. Provide regulatory support to different areas of the company.

3. Participate in the evaluation of change controls, risk assessments, and related activities.

4. Ensure regulatory compliance during the review and approval of assigned printed materials.

5. Support assigned labeling update processes.

6. Ensure the timely update of regulatory databases such as RIM and CCDS.

7. Complete all required training in VLearn and other platforms as nee

📌 Sr Analyst, Regulatory Affairs (Santiago)
🏢 Vantive
📍 Santiago

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