Regulatory Affairs Associate - FSP

Accountabilities: Support the preparation, coordination, and submission of local regulatory applications, including Market Authorization Applications (MAAs), product registrations, and control changes, in accordance with ANVISA requirements. Track and monitor regulatory submissions and follow up on their progress with local health authorities. Assist in preparing Module 1 documentation and other country-specific submission components. Monitor ANVISA regulatory updates, interpret relevant requirements, and communicate changes to internal stakeholders. Support audit and inspection readiness activities and contribute to the timely closure of Corrective and Preventive Actions (CAPAs). Assist with product labeling updates, including Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), and packaging materials, ensuring alignment with local requirements. Support the review of promotional materials to verify compliance with applicable regulations and approved product labeling. Maintain accurate regulatory records and submission information in Veeva Vault or equivalent systems. Help monitor regulatory compliance KPIs, submission timelines, and key milestones. Requirements: 2–3 years of experience in Regulatory Affairs, with direct exposure to ANVISA and Brazilian regulatory requirements. Practical experience supporting Market Authorization Applications (MAAs) and/or regulatory control changes. Knowledge of Brazilian regulatory submission processes, local labeling requirements, and submission documentation standards. Familiarity with Veeva Vault or similar regulatory information management systems; Veeva Vault experience is preferred. Bachelor's degree in Pharmacy, Biology, Chemistry, Natural Sciences, or a related field. An advanced degree is an advantage. Regulatory Affairs certification, such as RAC or an equivalent qualification, is a plus. Advanced or fluent English, with strong written and verbal communication skills in both English and Portuguese. Proficiency in Microsoft Office applications. Excellent attention to detail and accuracy when preparing and maintaining regulatory documentation. Strong organizational and time-management skills, with the ability to manage multiple activities and deadlines. Ability to collaborate effectively with cross-functional teams and communicate regulatory information clearly. Benefits: Remote work model based in Brazil. Full-time, sponsor-dedicated opportunity. Exposure to local regulatory submissions, product lifecycle management, and Brazilian pharmaceutical regulations. Opportunity to contribute to regulatory compliance and the development and availability of therapies that benefit patients. The source does not specify salary, healthcare coverage, or additional benefits.