Regulatory Affairs Manager
Pubblicato il 03-09-2026 - Regulatory Pharma Net - Rpn in Milano
We are looking for a Regulatory Affairs Manager to join our Regulatory Affairs Team.
Ha le carte in regola per avere successo? Le seguenti informazioni devono essere lette attentamente da tutti i candidati.
WHAT WILL YOU DEAL WITH?
Strategic Regulatory activities:
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- 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:
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- 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.
- 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?
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- 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 eff