Senior Manager, CMC Regulatory Affairs, Global Rare Diseases
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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 bonus
- 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
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