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 needed.

8.Fulfill the following responsibilities to ensure compliance with applicable regulations:

a) Ensure the accuracy of the information declared in the marketing authorization.

b) Maintain records of product registration resolutions, modifications, professional information, advertising, and all documentation sent to or received from the Institute.

c) Submit all information required by regulation to the Institute in a timely manner, when no other responsible party is designated.

d) Ensure that advertising and product information for pharmaceutical products comply with the marketing authorization and current health regulations.

e) Perform any additional functions assigned by applicable laws and regulations.

9.Coordinate with the Pharmacovigilance System Leader at Vantive to ensure compliance with the following functions:

a) Maintain a Pharmacovigilance system capable of collecting and evaluating information on adverse drug reactions reported to the marketing authorization holder and submit them to the Public Health Institute in the authorized forms, in Spanish, for products marketed in the country.

b) Submit Periodic Safety Update Reports (PSURs) for active ingredients as required by the Public Health Institute.

c) Submit Risk Management Plans and implement any actions required by the Public Health Institute.

d) Provide immediate responses to any information requests from the Public Health Institute regarding benefit–risk evaluations of medicines, within the established deadlines.

e) Maintain documentation related to suspected adverse drug reactions to enable follow-up when necessary.

f) Continuously evaluate the benefit–risk profile of marketed products and promptly notify authorities of any information that may impact this balance.

g) Collect safety information from post-marketing studies.

h) Report on the effectiveness of risk minimization measures included in Risk Management Plans.

i) Submit individual case safety reports within the timelines established by the National System for the Control of Pharmaceutical Products for Human Use. j) Comply with the submission frequency of PSURs as established by the Public Health Institute.

10.Ensure compliance with local regulations.

What You’ll Bring

• 1+ years of prior experience in regulatory affairs and quality, preferably in pharmaceuticals and medical devices.

• Degree in Pharmaceutical Chemistry (Required).

• Pharmacovigilance course for Marketing Authorization Holders.

• Prior experience with Chile’s Public Health Institute (ISP) and its regulatory platforms

• Intermediate English proficiency (Required).

• Experience in regulatory affairs management.

• Knowledge of applicable regulations for product registration.

• Knowledge of the pharmaceutical, medical device, and biomedical equipment sectors.

• Strong teamwork skills, fast learning ability, and adaptability to change.

• Competencies including proactivity, discipline, punctuality, responsibility, commitment, ability to work under pressure, and conflict resolution.

• Time management skills to meet expected objectives.

• Customer-oriented mindset.

• Fast response to incoming requests.

Reasonable Accommodation

Vantive 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. Form Link

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