Senior Regulatory Affairs Analyst

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LIBBS FARMACÊUTICA LTDA

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1958

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

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.

📋 Description

• Work with advanced technical knowledge in DIFA and CADIFA; • Be involved in an integrated manner from the prospecting and qualification of API manufacturers; • Support internal partners such as Supplier Qualification; • Present technical and regulatory strategies; • Work on risk management and technical and regulatory impact assessments; • Operate autonomously in project management; • Promote continuous improvements in the department's processes; • Provide technical and regulatory support to internal areas and API manufacturers; • Assess the impact of new regulations.

🎯 Requirements

• Bachelor's degree in a scientific field (Pharmacy, Biochemistry, Chemistry, or related areas); • Advanced English (reading, writing and speaking); • Extensive experience with national and international API (Active Pharmaceutical Ingredient) resolutions and guidance documents; • Experience in full DIFA analysis; • Experience negotiating requests for additional information/supplemental data with API manufacturers; • Maintenance of portfolio APIs and their precursors.

🏖️ Benefits

• Meal voucher (Vale Refeição); • Food allowance (Vale Alimentação); • 100% coverage for Libbs medications; • Pharmacy partnership – Vidalink; • Profit-sharing program (PPR - Company Profit and Results Participation Program); • Parking, transport voucher or company shuttle; • USE Program: subsidy for the purchase of equipment to be used for work; • Flexible benefits (TotalPass, life insurance, private pension plan, health insurance, dental care and additional meal allowance).