We are looking for a Regulatory Affairs Manager to join our Regulatory Affairs Team. WHAT WILL YOU DEAL WITH? Strategic Regulatory activities:
• 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:
• Preparing, reviewing, and overseeing regulatory documentation for Marketing Authorization Applications (MAA), including CTD Modules.
• Ensuring accuracy, completeness, and consistency of regulatory submissions, in line with international guidelines and client requirements.
• Planning, coordinating, and managing regulatory procedures (e.g. MAA, variations, line extensions, renewals) across EU and non‑EU markets. Cross‑functional & Project Management activities:
• 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‑agevolazioni approach. WHAT ARE THE REQUIREMENTS?
• 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. Contract details &

benefits:
• 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.
•

Location:
Milan
• 2–3 remote work days/week
• €10 meal voucher per on-site working days
• Competitive corporate welfare plan
• Birthday leave
• 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 The selection, respects Legislative Decree 198/2006 and is open to candidates of any orientation or expression of gender, sexual orientation, age, ethnicity and religious belief. This announcement is designed to respect diversity and inclusiveness.

📌 Regulatory Affairs Manager (Milano)
🏢 Regulatory Pharma Net - Rpn
📍 Milano