Reg Affairs Officer 1 - Fixed Term

Job Overview

Under general supervision, prepares and/or reviews regulatory submissions documents to support marketing authorization and post approval activities in Brazil for either internal and/or external clients. Provides regulatory support for assigned projects.

Essential Functions

• 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 Lifescience or related discipline.
• At least 2 years’ relevant experience in:

1.- In lifecycle maintenance, including registration and post approval variations for synthetics and biological drug products in Brazil.

2.- Assessment, preparation and submission of post-registration as well as annual reports for synthetic and biological drug products.

3.- Submission of local legal documents for Health Authority and GMP certificate in Brazil. Submission of legal documents for CVS, VISA, COVISA, and ANVISA, as applicable. Development, review and submission of leaflet and labeling artwork related applications.

4.- In regulatory information systems, change control assessments.

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

6.- Managing straight forward and lower complexity project activities with tight deadlines.

7.- Development, review and submission of leaflet and labeling artwork applications.

8.- Support in preparing assessments of national legislation, providing important and high-impact information for other areas. Participation in meetings with internal and external clients, in English, for providing regular project updates and discuss project's needs.

• Fluent conversational English
• Ability to work and collaborate effectively in a team environment and build positive working relationships across functions.
• Demonstrated ability to build positive working relationships with colleagues and stakeholders.
• Able to manage effectively multiple activities with tight deadlines, working with limited guidance and under senior staff supervision.
• Ability to effectively manage competing priorities and respond to urgent business needs.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.