Global CMC Regulatory Affairs Lead

Vertex Pharmaceuticals Inc (US); Boston (MA); Ibrido; USD 166.000 - 250.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid work option

On-site option

Descrizione del lavoro

Vertex is seeking an Associate Director of Chemistry, Manufacturing and Controls to execute global regulatory CMC strategies for investigational and marketed products. You will lead preparation and filing of CMC submissions and manage interactions with Health Authorities for CMC topics.

You will provide regulatory guidance to cross-functional teams, oversee change controls and GMP investigations, and supervise regulatory staff as needed.

Competenze

• Bachelor's degree in life sciences.
• 8 years of pharma/biotech regulatory experience.
• Advanced knowledge of FDA/EMA/ICH guidelines.

Mansioni

• Leads preparation/review of CMC submissions and agency interactions.
• Develops global CMC regulatory strategies for multiple products.
• Guides cross-functional teams on regulatory paths and submissions.
• Manages regulatory assessment of changes, deviations and GMP investigations.
• Acts as primary regulatory CMC contact for products/projects.
• Participates in development of department strategies and implementation.

Conoscenze

Interpersonal skills

Regulatory strategy

Cross-functional leadership

Planning and prioritization

Regulatory guidelines

Health authority interactions

Formazione

Bachelor's Degree in life sciences

Descrizione del lavoro

Vertex is seeking an Associate Director of Chemistry, Manufacturing and Controls to execute global regulatory CMC strategies for investigational and marketed products. You will lead preparation and filing of CMC submissions and manage interactions with Health Authorities for CMC topics.

You will provide regulatory guidance to cross-functional teams, oversee change controls and GMP investigations, and supervise regulatory staff as needed.