Regulatory Affairs Manager
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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.
- 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.
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.
- 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. This announcement is designed to respect diversity and inclusiveness.
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