Senior CMC Regulatory Affairs Lead — Global Submissions

Vertex Pharmaceuticals LLC; Boston (MA); Hybrid; USD 166,000 - 250,000; Full time

Job summary

Vertex Pharmaceuticals LLC in Boston, MA seeks an Associate Director of Regulatory CMC to lead global CMC strategies for investigational and marketed products. You will oversee the preparation and filing of CMC sections and interactions with Health Authorities, guiding cross-functional teams to ensure regulatory compliance.

The role may supervise staff, requires deep knowledge of FDA/EMA/ICH guidelines, and a collaborative, strategic approach to advance programs and deliver patient outcomes.

Qualifications

• 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

Responsibilities

• 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
• Participates in the design, development and implementation of department strategies, providing recommendations in area of expertise

Skills

Interpersonal skills

Strategic thinking

Problem solving

Cross-functional collaboration

Regulatory knowledge (FDA/EMA/ICH)

Education

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

Job description

Vertex Pharmaceuticals LLC in Boston, MA seeks an Associate Director of Regulatory CMC to lead global CMC strategies for investigational and marketed products. You will oversee the preparation and filing of CMC sections and interactions with Health Authorities, guiding cross-functional teams to ensure regulatory compliance.

The role may supervise staff, requires deep knowledge of FDA/EMA/ICH guidelines, and a collaborative, strategic approach to advance programs and deliver patient outcomes.