OverviewIn this role you will support Chiesi's Global Rare Diseases portfolio by managing CMC regulatory activities across submissions and lifecycle.
You will collaborate with Core teams, GCST, and external CMOs to ensure compliance and timely regulatory deliverables.
You will influence regulatory strategy and lead documentation for marketing authorisations, variations, and inspections.
This position offers high-impact work within a global, ambitious biotech environment that values sustainability and cross-functional partnership.
Retribuzione / Benefitsannual premio scheme
comprehensive benefits package
pension
private medical insurance
wellbeing programme
flexible benefits programme
ResponsabilitàCreate and maintain CMC regulatory documents to support submissions per GRDRA strategy
Lead CMC documents with Core team and GCST with minimal supervision
Represent GRDRA CMC at core-team level in global contexts
Author/review CMC sections for new and ongoing regulatory filings worldwide
Advise project teams on regulatory agency expectations for CMC content
Review change control requests related to CMC
Align regulatory strategy with GRDRA CMC functions and senior leadership




Maintain submission information and track CMC commitments/timelines
Collaborate with external CMOs and cross-functional teams on process improvements, scale-up, and tech transfer
Support development of SOPs and due diligence activities for CMC
Represent GRDRA during GMP inspections when required
Stay updated on evolving regulatory CMC requirements
Requisiti fondamentaliBachelor's degree in a Scientific/Technical discipline (advanced degree preferred)
7+ years of Regulatory CMC experience
3+ years in Biologics/Biopharmaceuticals
Advanced knowledge of global CMC regulations (ICH, US/EU)
Experience in authoring CTD M2/M3 and lifecycle management of quality variations
Proficiency with quality management software (TrackWise) and regulatory document management systems
Strong attention to detail and multi-tasking
Effective communication and problem-solving skills
Ability to work independently and in a fast-paced environment
Attention to detail
Strong communication (oral, written, interpersonal)
Critical thinking
CMC regulatory knowledge (ICH; US/EU)
CTD M2/M3 authoring
Life cycle management of variations

📌 Senior Manager, Cmc Regulatory Affairs, Global Rare Diseases (Emilia-Romagna)
🏢 Chiesi
📍 Emilia-Romagna