When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal
- to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special
- a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
We are looking for a Senior Regulatory Affairs Manager/Consultant with 10+ years of experience in regulatory affairs, including CMC expertise. This challenging role offers the opportunity to work on diverse projects, manage client relationships, and contribute to regulatory strategies in a global pharmaceutical environment.
This is a client dedicated project, without people management responsibility. The role can be home or office based in various European locations.

Key Responsibilities




Write CMC sections and scientific rationales for regulatory submissions and responsesDevelop and implement variations strategies based on EU guidelinesCoordinate CMC activities across multiple projectsLiaise with global affiliates and manufacturing sitesProvide project leadership and managementEnsure client satisfaction and project qualityIdentify new business opportunities and contribute to proposal preparationRequired

Qualifications:
10+ years of experience in regulatory affairsExtensive knowledge of CMC writing and variations strategyWorking knowledge of vaccines or biological processes
- requiredExperience with regulatory agencies (e.g., FDA, EMA, MHRA)In-depth understanding of EU guidelines (Variation, ICH, EMA)Excellent project management and organizational skillsStrong communication abilities and client management experienceAbility to work independently and as part of a teamFluent in English written and spoken; additional languages are a plusSummaryLocation: United Kingdom-Harrow-Remote; United Kingdom-London-Gridiron; Croatia-Remote; Hungary-Budapest; Ireland-Dublin; Hungary-Remote; Croatia-Zagreb; Poland-Warsaw-Business Garden; Poland-Remote; Romania-Remote; Italy-Milan; Serbia-Belgrade; Spain-Remote; Italy-Remote; Serbia-Remote; Romania-Bucharest-Metropolis Center; Spain-Madrid; Ireland-RemoteType: Tempo pieno

📌 Senior Regulatory Affairs Manager (Milano)
🏢 Parexel
📍 Milano