Senior CMC Regulatory Affairs Manager Global Rare Diseases

Chiesi Farmaceutici S.p.A.; Parma; In loco; EUR 59.000 - 74.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pension

Private medical insurance

Wellbeing programme

Flexible benefits programme

Relocation support

Descrizione del lavoro

Chiesi Farmaceutici S.p.A. seeks an experienced Senior Manager, CMC Regulatory Affairs for its Global Rare Diseases portfolio. The role focuses on post-approval CMC activities, coordinating with global teams and CMOs to ensure high-quality submissions.

You will shape regulatory strategies across development and marketed products, maintain timelines, and drive continuous improvement in CMC documentation and submission readiness. Based in Europe, with flexible options.

Competenze

• Bachelor’s degree in a scientific or technical discipline is required; an advanced degree is preferred.
• Minimum of six years of regulatory CMC experience for small molecules, herbal medicinal and/or biological products.
• Advanced knowledge of global CMC regulations (ICH and US/EU/Canada).
• Experience with CTD Modules 2 and 3, post‑approval changes lifecycle, and regulatory submissions.

Mansioni

• Author and/or review CMC sections for the GRD portfolio, including NAAs, variations, renewals, and annual reports.
• Advise project teams on regulatory agency requirements for CMC submissions.
• Collaborate with CMOs and cross-functional teams to obtain CMC documentation.
• Develop regulatory strategies for products in development and marketed GRD products.
• Prepare timely responses to CMC regulatory questions with SMEs.

Conoscenze

Communication skills

Attention to detail

Project management

Team collaboration

Formazione

Bachelor's degree in scientific discipline

Advanced degree preferred

Strumenti

TrackWise

Veeva RIM

Descrizione del lavoro

Chiesi Farmaceutici S.p.A. seeks an experienced Senior Manager, CMC Regulatory Affairs for its Global Rare Diseases portfolio. The role focuses on post-approval CMC activities, coordinating with global teams and CMOs to ensure high-quality submissions.

You will shape regulatory strategies across development and marketed products, maintain timelines, and drive continuous improvement in CMC documentation and submission readiness. Based in Europe, with flexible options.