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‑vantaggi 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 & benef

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