Global Regulatory CMC Technical Lead

ClinChoice; Italia; In loco; EUR 90.000 - 140.000; Tempo pieno

Descrizione del lavoro

ClinChoice is seeking a Regulatory CMC Technical Lead Consultant in Italy to drive regulatory CMC submissions and lifecycle management for global products. You will author and review CTD M2/M3 sections, coordinate with core teams, and ensure alignment with global regulatory expectations.

You will collaborate cross-functionally with development teams, CMOs, and inspectors, maintain submission records, and guide project teams on strategy and compliance.

Competenze

• Regulatory CMC experience for drug development.
• Authoring CTD sections and lifecycle management.
• Regulatory strategy knowledge across ICH, US/EU.

Mansioni

• Maintain or create CMC regulatory documents for products.
• Manage CMC regulatory documents with minimal supervision.
• Act as CMC representative in core teams globally.
• Author/review CMC sections for MAAs, Investigational Apps, variations.
• Advise teams on regulatory requirements for CMC submissions.
• Review change controls affecting CMC; track commitments.
• Negotiate regulatory strategies with agencies; collaborate cross-functionally.
• Support SOP development and regulatory due diligence.
• Represent during GMP inspections when required.
• Stay updated on global CMC regulations (ICH, US/EU).

Conoscenze

CMC regulatory knowledge

CTD M2/M3 authoring

Regulatory submissions

Project management

Attention to detail

Effective communication

Formazione

Bachelor's degree in Science/Engineering

Strumenti

TrackWise

Descrizione del lavoro

ClinChoice is seeking a Regulatory CMC Technical Lead Consultant in Italy to drive regulatory CMC submissions and lifecycle management for global products. You will author and review CTD M2/M3 sections, coordinate with core teams, and ensure alignment with global regulatory expectations.

You will collaborate cross-functionally with development teams, CMOs, and inspectors, maintain submission records, and guide project teams on strategy and compliance.