Regulatory Affairs Analyst – Mid-level

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LIBBS FARMACÊUTICA LTDA

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Pharmaceuticals • Biotechnology • Healthcare Insurance

LIBBS FARMACÊUTICA LTDA is a Brazilian pharmaceutical company with a focus on producing biological medications and a commitment to innovation and research. Established for over 67 years, the company employs around 3,800 people and is recognized as one of the top laboratories in the pharmaceutical retail sector in Brazil. LIBBS specializes in various therapeutic areas, including cardiometabolic, dermatology, gastrointestinal, gynecological, hematological, oncological, respiratory, and central nervous system treatments, with over 100 product brands and a strong emphasis on improving patient health and well-being.

1001 - 5000 employees

Founded 1958

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

📋 Description

• Assess the regulatory feasibility of post-registration/post-approval changes (define the clinical-regulatory pathway and post-registration classification) • Execute and monitor post-registration processes, including PGMP, responding to regulatory requests, and supporting product launches • Evaluate change controls with a focus on regulatory impact and classification • Perform regulatory activities related to the product life cycle, covering HMP, discontinuation and cancellation processes, recalls, registration renewals, and GMP certificates (CBPF) of international partners • Support analysis of deviations and quality notifications, ensuring compliance with regulatory requirements • Interact with international partners to ensure regulatory compliance throughout the product life cycle • Coordinate with internal and external stakeholders to define regulatory strategies and meet deadlines • Contribute to critical analysis and continuous improvement of internal regulatory workflows

🎯 Requirements

• Bachelor’s degree in Pharmacy or Chemistry • Advanced English (spoken and written) • Proficiency in Microsoft Office • Knowledge of post-registration/post-approval processes, PGMP, and product life-cycle activities, including familiarity with applicable legislation for these processes • Experience in development and validation of analytical methods, drug stability, pharmaceutical equivalence studies and dissolution profiles, biowaivers, ANVISA regulations related to drug quality (e.g., RDC 964/25, RDC 31/10, RDC 318/19, RDC 166/17, RDC 749/22), pharmaceutics processes, and drug development

🏖️ Benefits

• Meal voucher • Food allowance • Libbs medications – 100% covered • Pharmacy agreement – Vidalink • PPR – Company Profit and Results Sharing Program • Parking, transit voucher, or company shuttle (applicable only for shift work) • USE Program: subsidy to purchase equipment to be used for work, which may also be used for personal purposes • Flexible benefits (TotalPass, life insurance, private pension, health insurance, dental care, and meal allowance)