Regulatory Affairs Manager
Company: Regulatory Pharma Net
- Location: Pisa, Italy
- Work mode: Remote
- Seniority: Mid level
- Posted: Yesterday
- Offer language: English
Job description
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‑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.
Contract details & benefits:
- CCNL Commercial Sector
- Type of contract: permanent
- Salary (RAL): starting from €40,000 (the 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 process complies with Article 5 of Legislative Decree No. 96/2026 and Legislative Decree No. 198/2006 and is open to candidates regardless of gender identity or expression, sexual orientation, age, ethnicity, or religious belief. This job posting has been drafted in accordance with the principles of diversity, inclusion, and pay transparency.
