# Regulatory Submissions Coordinator

**Company**: IQVIA
**Experience**: mid
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/So-Paulo-Brazil/Reg-Affairs-Officer-1_R1571294-2?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_2624ad03-518

## Description

We are seeking a Regulatory Submissions Coordinator to provide regulatory support for assigned projects in Brazil.

The successful candidate will prepare and review regulatory submissions documents to support marketing authorization and post-approval activities for internal and external clients.

Responsibilities:

- Perform timely updates to regulatory databases following approvals, variations, renewals, extensions, and other lifecycle activities

- Manage the creation, review, and maintenance of regulatory documents and records in accordance with established procedures

- Support change control assessments by evaluating the regulatory impact of proposed product, manufacturing, labeling, and quality changes

- Collaborate with cross-functional teams, including Regulatory Affairs, Quality, Manufacturing, Supply Chain, and Pharmacovigilance, to maintain current regulatory information

- Track and maintain regulatory commitments, submission milestones, and approval documentation

- Support preparation and maintenance of regulatory dossiers and lifecycle submissions

- Contribute to process improvements related to regulatory information management and document maintenance

- Ensure compliance with applicable regulatory requirements and internal quality standards

Qualifications:

- Bachelor's Degree in Life Sciences or related discipline

- At least 2 years of relevant experience in lifecycle maintenance, assessment, preparation and submission of post-registration, and regulatory information systems

- Hands-on experience with CADIFA, including maintenance of regulatory documentation, product records, and lifecycle management data

- Fluent conversational English

- Ability to work effectively in a team environment and build positive working relationships across functions

## Skills

### Required
- Life Sciences
- Regulatory Affairs
- CADIFA
- English

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Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/So-Paulo-Brazil/Reg-Affairs-Officer-1_R1571294-2?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)