CMC Regulatory Lead, Global Rare Diseases

Chiesi Usa, Inc.; Cary (NC); Ibrido; USD 121.000 - 182.000; Tempo pieno

Vantaggi offerti da questo lavoro

Healthcare program

Relocation support

Flexible working arrangements

Remote work options

Descrizione del lavoro

Chiesi Usa, Inc. in Cary, NC seeks a Regulatory Affairs Manager with strong CMC pre- and post-approval experience to support our Global Rare Diseases portfolio.

You will lead regulatory submissions, communicate with agencies, and guide cross-functional teams through lifecycle activities. The role requires a bachelor’s degree in a scientific or technical discipline and 5+ years in Regulatory CMC, with knowledge of ICH and US/EU requirements.

Competenze

• Bachelor’s degree in a Scientific or Technical field required.
• 5+ years of Regulatory CMC experience.
• Strong knowledge of global CMC regulations (ICH, US/EU).
• Experience authoring CTD M2/M3 and lifecycle mgmt of variations.
• Proficient with TrackWise and regulatory document systems.

Mansioni

• Maintain or create CMC regulatory documents for a broad range of submissions.
• Collaborate with Core team and GCST with full responsibility and no supervision.
• Represent GRDRA CMC at core team level, globally when required.
• Author/review CMC sections for marketing applications, submissions, variations.
• Advise on regulatory agency requirements for CMC sections in dossiers.
• Review and assess change control requests related to CMC.
• Define regulatory strategy with GRDRA and senior leadership for product lifecycle.
• Track submission information and CMC commitments with minimal supervision.
• Collaborate with CMOs and cross-functional teams on process improvements.

Conoscenze

Regulatory CMC experience

ICH regulations

Documentation

Cross-functional collaboration

Regulatory strategy

Attention to detail

Independent work

Communication skills

Formazione

Bachelor's degree in a Scientific or Technical Discipline

Advanced degree preferred

Strumenti

TrackWise

Regulatory DMS

Descrizione del lavoro

Chiesi Usa, Inc. in Cary, NC seeks a Regulatory Affairs Manager with strong CMC pre- and post-approval experience to support our Global Rare Diseases portfolio.

You will lead regulatory submissions, communicate with agencies, and guide cross-functional teams through lifecycle activities. The role requires a bachelor’s degree in a scientific or technical discipline and 5+ years in Regulatory CMC, with knowledge of ICH and US/EU requirements.