Regulatory Affairs Manager

2 giorni fa
Milano, Provincia di Milano; Lombardia, Italia Regulatory Pharma Net - RPN Tempo pieno
We are looking for a Regulatory Affairs Manager to join our Regulatory Affairs Team. Supporting the definition of global and regional regulatory strategies, identifying optimal registration pathways based on product characteristics, development stage and target markets. Providing strategic guidance to clients on regulatory requirements and potential risks, ensuring compliance with EU and international frameworks. Regulatory Affairs activities: Ensuring accuracy, completeness, and consistency of regulatory submissions, in line with international guidelines and client requirements. Planning, coordinating, and managing regulatory procedures (e.g. Providing regulatory support to clinical development and CMC projects , ensuring alignment with overall development plans. Coordinating multidisciplinary teams and managing timelines to ensure high-quality deliverables and compliance with deadlines. Supporting clients in regulatory decision-making through a risk-benefit approach. Master's degree in Pharmaceutical Chemistry and Technology, Pharmacy, or related scientific fields. At least 5 of experience in Regulatory Affairs within the pharmaceutical sector. Strong knowledge of EU and international regulatory frameworks (EMA, FDA, ICH), with experience managing multi-country projects. Excellent command of English , both written and spoken. Strong project management skills, excellent communication abilities, and a team oriented mindset , with the capacity to coordinate complex projects, facilitate stakeholder dialogue, and collaborate effectively within multidisciplinary teams. CCNL Commercial Sector Type of contract: permanent Salary range (RAL): €40,000
- €45,000. The actual compensation offered may vary based on several factors, including job-related qualifications such as knowledge, skills, education, experience, and location. Buddy program for onboarding: from day one, you'll be supported by a dedicated contact to help you settle in and integrate with the team

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