Regulatory Affairs Analyst, Mid

Job not on LinkedIn

🔥 12 minutes ago

🗣️🇧🇷🇵🇹 Portuguese Required

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Logo of Soulan Recursos Humanos

Soulan Recursos Humanos

51 - 200 employees

Founded 1988

🎯 Recruiter

🤝 B2B

Recruitment • B2B

<Soulan Recursos Humanos> is a Brazilian human-resources consultancy and strategic people-management partner with over 35 years of experience. The company offers tailored recruitment, talent acquisition, workforce management and HR consulting services for businesses across Brazil, emphasizing rapid, high-volume recruitment, temporary staffing and talent development. Soulan highlights national presence, a large talent pool (reported +30 million), thousands of corporate clients and extensive experience in staffing and HR solutions.

📋 Description

• Support the Regulatory Affairs teams (New Registrations and Portfolio) in the processes for new product registrations and post‑registration activities, as well as related documentation, ensuring compliance with current regulations regarding Active Pharmaceutical Ingredient (API) • Evaluate the Drug Master File (DMF) based on current DIFA and CADIFA legislative concepts, and assess the impact of DMF information in light of new regulations, considering the applicability of the intended new assumptions to routine operations... • Manage deadlines, organization, and control of project information (follow‑up with suppliers and internal peers)...

🎯 Requirements

• Degree in Pharmacy, Biochemistry, Chemistry, or related fields • Intermediate English – reading and writing • Experience in comprehensive DIFA analysis, evaluation of synthesis routes for synthetic and semi‑synthetic APIs, and impurity profiling • Experience maintaining APIs in the portfolio and their precursors, from monitoring and assessing changes implemented by manufacturers to developing internal strategies for post‑registration regulatory updates in accordance with current regulations

🏖️ Benefits

• Life insurance • Transportation allowance • Meal voucher • Health insurance

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