Regulatory Affairs Manager

Description

Job Summary: We are seeking a Regulatory Affairs Manager to lead the regulatory strategy, oversee product registrations, and ensure compliance with national and international health regulations. Key Highlights: 1. Lead the company's regulatory strategy 2. Ensure compliance with national and international regulations 3. Maintain effective communication with regulatory agencies Regulatory Affairs Manager **Location:** Valparaíso, Valparaíso Region, Chile **Company:** CGM Pharma SpA About Us CGM Pharma SpA is a pharmaceutical company committed to innovation, quality, and regulatory compliance in the development of medicines and health products. Our goal is to ensure that every process meets the highest national and international regulatory standards. Job Description We are seeking a **Regulatory Affairs Manager** to lead the company’s regulatory strategy, supervise registration processes, and ensure compliance with health regulations. The selected candidate will be responsible for coordinating with regulatory authorities and supporting the team in documentation and technical management. Key Responsibilities * **Regulatory Management**: Supervise health registrations and authorizations for pharmaceutical products. * **Regulatory Compliance**: Ensure alignment with local and international regulations (ISP, FDA, EMA). * **Authority Engagement**: Maintain effective communication with regulatory agencies. * **Documentation Management**: Coordinate preparation and review of technical dossiers. * **Risk Assessment**: Identify potential regulatory contingencies and propose solutions. * **Internal Training**: Train staff on regulations and good regulatory practices. * **Corporate Strategy**: Support senior management in strategic decisions related to regulations. Requirements * Degree in Pharmacy and Chemistry, Biochemistry, Biotechnology Engineering, or related field. * 5–7 years of experience in pharmaceutical regulatory affairs. * Advanced knowledge of national and international regulations. * Experience in health registration management and regulatory audits. * Leadership, organizational, and strategic communication skills. * Advanced English (spoken and written). Benefits * Competitive salary (average range in Chile: **CLP 2\.000\.000–2\.600\.000** per month). * Health insurance and corporate benefits. * Opportunities for training on international regulations. * Professional and collaborative work environment. Salary: $2\.300\.000 per month Workplace: On-site employment