Overview
In this Senior Manager CMC Regulatory Affairs role, you drive global CMC submissions for Chiesi Global Rare Diseases, shaping regulatory strategies and interactions with authorities.
You work cross-functionally with CMOs and internal teams to assemble documentation, respond to questions, and ensure timely, high-quality filings.
You'll influence process improvements and maintain compliance across markets, contributing to the portfolio's growth and patient impact.
This position offers visibility across international teams and regulatory inspections, with a focus on ensuring robust quality and timely approvals.
Retribuzione / Benefits
pension
private medical insurance
wellbeing programme
flexible benefits programme
annual premio
relocation support
Responsabilità
Author/review CMC sections for GRD portfolio across submissions (marketing authorizations, extensions, supplements, renewals, annual reports)
Advise cross-functional teams on regulatory CMC requirements
Collaborate with CMOs and teams to obtain CMC documentation for submissions
Develop regulatory strategies aligned with GRD RA CMC leadership
Prepare responses to CMC regulatory questions with SMEs
Coordinate process optimization, scale-up, and technology transfer with external partners




Review/assess change control requests related to CMC and plan filing strategies
Maintain CMC submission templates and document management system records
Track regulatory CMC commitments and timelines for projects and markets
Support SOPs and process development for RA CMC team
Represent GRD RA during GMP inspections when permitted
Maintain up-to-date knowledge of global CMC regulations and guidelines
Requisiti fondamentali
Bachelor's degree in a scientific or technical discipline; an advanced degree preferred
Minimum 6 years regulatory CMC experience (small-molecule, herbal, and/or biological products)
Advanced knowledge of global CMC regulations (ICH, US, EU, Canada)
Experience authoring CTD Modules 2 and 3; lifecycle management of post-approval changes
Experience with TrackWise and Veeva RIM is a plus
Strong attention to detail and commitment to quality
Ability to manage competing priorities and meet deadlines
Excellent written/verbal/interpersonal communication; strong critical-thinking and problem-solving
Proven ability to work independently and in cross-functional teams
Clear communication
Attention to detail
Time management
CMC regulatory expertise
CTD Modules 2 and 3 authoring
Regulatory submissions planning

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