Regulatory Affairs Analyst

We are looking for a Regulatory Affairs Analyst to support regulatory submissions, product registrations, compliance activities, and regulatory data management. This professional will work closely with regional teams and internal stakeholders to ensure that regulatory documentation, systems, and submissions are accurate, organized, compliant, and completed within the required timelines.

Key Responsibilities
• Execute post-approval activities, including database reviews and preparation of communications for relevant stakeholders.
• Update internal systems with regulatory information, data, and supporting documentation.
• Review product labels in internal systems to ensure compliance with applicable regulatory requirements.
• Support the submission of regulatory changes, amendments, rectifications, and renewals within established timelines and under appropriate guidance.
• Assist with establishment registration and licensing activities.
• Request, collect, and follow up on documentation required for the preparation of product registration dossiers.
• Support regional teams with product submission schedules, prioritization, pipeline management, and regulatory planning.
• Act as a point of contact for stakeholders, supporting business plans and regulatory requirements.
• Represent the country or regulatory subject area in relevant projects and cross-functional initiatives.
• Support compulsory certification activities and follow up on the required documentation and processes.
• Maintain regulatory files, records, and archives in an accurate and organized manner.
• Organize team meetings and prepare agendas, meeting minutes, and follow-up actions.
• Maintain strong adherence to internal procedures, regulatory standards, and compliance requirements.
• Manage and analyze complex regulatory information using Excel spreadsheets and other tracking tools. Requirements
• Experience or knowledge in Regulatory Affairs, product registration, compliance, quality, or a related area.
• Understanding of regulatory submissions, post-approval activities, renewals, amendments, and document management.
• Strong attention to detail and ability to work with complex data and regulatory documentation.
• Proficiency in Microsoft Excel and the ability to manage reports, trackers, and spreadsheets.
• Strong organizational skills, with the ability to manage multiple priorities and deadlines.
• Effective communication and stakeholder management skills.
• Ability to work collaboratively with regional and cross-functional teams.
• Strong commitment to compliance, accuracy, and data integrity.
• Advanced English proficiency, both written and spoken. Igualdade & Oportunidade para Todos Representando 165 nacionalidades em todo o mundo, nos orgulhamos de ser um empregador que oferece igualdade de oportunidades, comprometido em fornecer oportunidades iguais de emprego a todos os candidatos e funcionários, independentemente de raça, religião, sexo, cor, idade, nacionalidade, gravidez, orientação sexual, deficiência física ou informações genéticas, ou qualquer outra classificação protegida, de acordo com as leis federais, estaduais e/ou locais.