Regulatory Affairs Officer 1 - Fixed Term

About the role

IQVIA is hiring a Reg Affairs Officer 1 on a fixed-term basis in São Paulo. Working under general supervision, you prepare and/or review regulatory submission documents supporting marketing authorization and post-approval activities in Brazil for internal and/or external clients, and provide regulatory support for assigned projects.

Key responsibilities

• Keep regulatory databases up to date after approvals, variations, renewals, extensions and other lifecycle activities.
• Create, review and maintain regulatory documents and records according to established procedures.
• Evaluate the regulatory impact of proposed product, manufacturing, labeling and quality changes for change control assessments.
• Work with Regulatory Affairs, Quality, Manufacturing, Supply Chain and Pharmacovigilance to keep regulatory information current.
• Track regulatory commitments, submission milestones and approval documentation.
• Support preparation and maintenance of regulatory dossiers and lifecycle submissions.
• Contribute to process improvements for regulatory information management and document maintenance.
• Ensure compliance with regulatory requirements and internal quality standards.

Required profile

• Bachelor's degree in Life Sciences or a related discipline.
• At least 2 years' relevant experience in lifecycle maintenance, registration and post-approval variations for synthetic and biological drug products in Brazil.
• Experience assessing, preparing and submitting post-registration and annual reports, and submitting legal documents to Health Authorities, GMP certificates and agencies such as ANVISA, CVS, VISA and COVISA.
• Hands-on experience with CADIFA, including maintenance of regulatory documentation, product records and lifecycle management data.
• Ability to manage straightforward, lower-complexity projects with tight deadlines and multiple competing priorities with limited guidance.
• Fluent conversational English; able to attend client meetings in English and give project updates.
• Team player who can build positive working relationships across functions.