Senior Regulatory Affairs Analyst – Pharmaceuticals

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Act as a Senior Regulatory Affairs Analyst with a focus on pharmaceuticals.

• Manage regulatory processes for products overseen by health authority Anvisa.

• Oversee pre-registration actions, marketing authorization requests, post-approval submissions, and pharmaceutical renewals.

• Evaluate relevant legislation, regulatory strategies, and Anvisa’s administrative and technical protocols.

• Analyze the feasibility of registering or notifying pharmaceuticals, especially biological products.

• Review clinical studies, bioequivalence studies, and scientific literature to demonstrate safety and efficacy.

• Examine development and manufacturing documents, specifications, analytical methods, validations, stability studies, and degradation products.

• Prepare and submit GMP certification applications and regulatory dossiers to Anvisa.

• Draft technical reports in English, package leaflets, and review labeling in line with current regulations.

• Track applications, the Official Gazette of Brazil, pertinent news, and review queues.

• Engage in meetings with Anvisa and provide support to both domestic and international clients, including in English.

⛳️ Requirements

• Academic qualification: Pharmacy.

• Significant experience in Regulatory Affairs for products under Anvisa's health authority oversight.

• Proven experience with pre-registration actions, marketing authorization requests, and post-approval submissions.

• Familiarity with relevant legislation and regulatory strategies.

• Knowledge of Anvisa’s administrative and technical procedures.

• Experience in assessing the feasibility of registering or notifying pharmaceuticals, particularly biological products, including vaccines, innovative products, and biosimilars.

• Background in evaluating clinical studies and/or scientific literature to establish safety and efficacy.

• Experience in analyzing specifications, analytical methods, and validations.

• Proficient in examining stability studies and testing per applicable technical standards.

• Experience in preparing and submitting GMP certification applications.

• Advanced proficiency in formal written and spoken Portuguese.

• Exceptional reading comprehension and text interpretation skills in both Portuguese and English.

• Advanced English capabilities, encompassing fluent reading, writing, listening, and speaking.

• Proficient in Windows, Microsoft Office (Word, Excel, PowerPoint, and Outlook), and Anvisa systems.

• Postgraduate degree in Regulatory Affairs, Health Surveillance, or the Pharmaceutical Industry is preferred.

• Experience in Regulatory Affairs related to active pharmaceutical ingredients, cannabis products, biological products, clinical research, medical devices, cosmetics, and sanitation products is a plus.

🏝️ Benefits

• Education and professional development allowance.

• Health allowance.

• Remote working options and flexible hours.

• Flexible absence policy.

• Compensation system for working hours.

• Year-end break and Carnival Wednesday holiday.