Global CMC Regulatory Lead

MFS Investments; Boston (MA); Ibrido; USD 166.000 - 250.000; Tempo pieno

Descrizione del lavoro

Vertex is seeking a Chemistry Manufacturing Controls Associate Director to execute global regulatory CMC strategies for multiple products, including preparation of submissions and interactions with Health Authorities. This role provides regulatory guidance to cross-functional teams and may supervise staff.

The position leads global CMC strategies for investigational and marketed products, liaises with agencies, and ensures compliance with FDA, EMA, Health Canada, and ICH guidelines.

Competenze

• Bachelor's degree in biology, chemistry, pharmacy, regulatory affairs for drugs, biologics or medical devices, or another life-science field.
• Typically requires 8 years of experience in the pharmaceutical or biotech industry or in a related field, or the equivalent combination of education and experience.

Mansioni

• Leads the preparation and review of CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
• Develops global CMC regulatory strategies for one or more investigational and/or marketed products
• Leads regulatory colleagues in development of global CMC regulatory strategies and submissions
• Provides CMC regulatory guidance to cross-functional teams and key stakeholders
• Manages regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
• Leads projects with cross-functional teams and acts as the primary regulatory CMC contact for assigned products and projects

Conoscenze

Interpersonal skills

Strategic thinking

Problem solving

Cross-functional collaboration

Regulatory knowledge

Formazione

Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field

Descrizione del lavoro

Vertex is seeking a Chemistry Manufacturing Controls Associate Director to execute global regulatory CMC strategies for multiple products, including preparation of submissions and interactions with Health Authorities. This role provides regulatory guidance to cross-functional teams and may supervise staff.

The position leads global CMC strategies for investigational and marketed products, liaises with agencies, and ensures compliance with FDA, EMA, Health Canada, and ICH guidelines.