Overview
In 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 / Benefits
- annual bonus scheme
- comprehensive benefits package
- pension
- private medical insurance
- wellbeing programme
- flexible benefits programme
Responsabilità
- Create 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 fondamentali
- Bachelor’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 datore di lavoro: Chiesi
Lavorare con noi significa essere parte di un team innovativo e dedicato, impegnato a trasformare la salute nelle malattie rare. Offriamo un ambiente di lavoro flessibile e collaborativo, con opportunità di crescita professionale e sviluppo delle competenze nel campo delle evidenze reali. I nostri dipendenti beneficiano di un programma di benessere completo, supporto per il trasferimento e opzioni di lavoro remoto, rendendo la nostra azienda un datore di lavoro eccezionale per chi cerca un impatto significativo nella sanità.
