Senior Regulatory Affairs Manager - Cmc (Various Locations) Milano

Senior Regulatory Affairs Manager - Cmc (Various Locations)
Milano
Lombardia, Milano

When our values align, there's no limit to what we can achieve.

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 (23S, 23P, 32S, 32P) 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 strategyIn-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 teamProficiency in English; additional languages are a plusPreferred Qualifications:Experience with regulatory agencies (e. g. , FDA, MHRA)Industry-recognized certifications or advanced degreesPublication history or experience presenting at industry conferences