We are looking for a Regulatory Affairs Manager to join our Regulatory Affairs Team.

Tutti i candidati sono invitati a leggere attentamente la seguente descrizione del lavoro e le relative informazioni prima di candidarsi.
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-vantaggi 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 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.

- 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. xjncmbx This announcement is designed to respect diversity and inclusiveness.

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📌 Regulatory Affairs Manager (Romano di Lombardia)
🏢 Regulatory Pharma Net - Rpn
📍 Romano di Lombardia