Senior Regulatory Affairs Analyst – Pharmaceuticals

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🔥 1 hour ago

🇧🇷 Brazil – Remote

⏳ Contract/Temporary

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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Visanco - Consultoria em Assuntos Regulatórios na Área de Vigilância Sanitária

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 1997

🍽️ Food & Beverage

📦 Logistics

⚖️ Legal

Food & Beverage • Logistics • Legal

Visanco is a specialized Technical Consultancy Company established in 1997, based in Brasília, Brazil. It provides services focused on Regulatory Affairs in the health sector, assisting businesses in navigating the complex landscape of health surveillance and inspection. The company supports over 600 clients, including national and international firms, with a wide range of services such as quality control systems, regulatory compliance, and product registration. Visanco's team comprises qualified professionals from various fields, including nutrition, pharmacy, and health management, ensuring comprehensive support in adhering to health regulations and standards.

📋 Description

• Serve as a Senior Regulatory Affairs Analyst focused on pharmaceuticals • Handle regulatory processes for products subject to health authority oversight by Anvisa • Manage pre-registration measures, marketing authorization applications, post-approval submissions, and pharmaceutical renewals • Assess applicable legislation, regulatory strategies, and Anvisa’s administrative and technical procedures • Evaluate the feasibility of registering or notifying pharmaceuticals, particularly biological products • Assess clinical studies, bioequivalence studies, and scientific literature to demonstrate safety and efficacy • Analyze development and manufacturing documents, specifications, analytical methods, validations, stability studies, and degradation products • Prepare and submit GMP certification applications and regulatory dossiers to Anvisa • Prepare technical reports in English, package leaflets, and review labeling in accordance with current legislation • Monitor applications, the Official Gazette of Brazil, relevant news, and review queues • Participate in meetings with Anvisa and support domestic and international clients, including in English

🎯 Requirements

• Academic background: Pharmacy • Substantial experience in Regulatory Affairs for products subject to health authority oversight by Anvisa • Experience with pre-registration measures, marketing authorization applications, and post-approval submissions • Knowledge of applicable legislation and regulatory strategies • Knowledge of Anvisa’s administrative and technical procedures • Experience evaluating the feasibility of registering or notifying pharmaceuticals, particularly biological products, including vaccines, innovative products, and biosimilars • Experience evaluating clinical studies and/or scientific literature to demonstrate safety and efficacy • Experience analyzing specifications, analytical methods, and validations • Experience analyzing stability studies and testing in accordance with applicable technical standards • Experience preparing and submitting GMP certification applications • Advanced command of formal written and spoken Portuguese • Excellent reading comprehension and text interpretation skills in Portuguese and English • Advanced English proficiency, including fluent reading, writing, listening, and speaking • Proficiency with Windows, Microsoft Office (Word, Excel, PowerPoint, and Outlook), and Anvisa systems • Postgraduate qualification in Regulatory Affairs, Health Surveillance, or the Pharmaceutical Industry — desirable • Experience in Regulatory Affairs for active pharmaceutical ingredients, cannabis products, biological products, clinical research, medical devices, cosmetics, and sanitation products — desirable

🏖️ Benefits

• Education and professional development allowance • Health allowance • Remote work and flexible hours • Flexible scheduled absence policy • Working-hours compensation system • Year-end break and Carnival Wednesday holiday

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