Global CMC Regulatory Strategy Lead

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

Job summary

Vertex Pharmaceuticals Incorporated seeks an Associate Director to drive multi‑product regulatory CMC strategies for investigational and marketed products. You will lead CMC submissions, guide cross‑functional teams, and interact with Health Authorities while ensuring global regulatory compliance.

You may supervise regulatory staff and collaborate across functions to design department strategies, with a focus on FDA/EMA/Health Canada and ICH guidelines.)

Qualifications

• Bachelor's degree in biology, chemistry, pharmacy, regulatory affairs or life sciences.
• Typically 8 years of pharma/biotech experience or equivalent.
• Strong knowledge of FDA, EMA, Health Canada and ICH guidelines.

Responsibilities

• Lead preparation and review of CMC sections of regulatory submissions and interactions with regulators.
• Develop global CMC regulatory strategies for investigational and marketed products.
• Guide cross-functional teams on CMC topics and ensure compliance.
• Oversee change controls, deviations and GMP investigations as part of product compliance.
• Act as primary regulatory CMC contact for assigned products and projects.

Skills

CMC submissions

Regulatory strategy

Cross-functional collaboration

Regulatory guidelines

Project leadership

Education

Bachelor's degree in life sciences

Job description

Vertex Pharmaceuticals Incorporated seeks an Associate Director to drive multi‑product regulatory CMC strategies for investigational and marketed products. You will lead CMC submissions, guide cross‑functional teams, and interact with Health Authorities while ensuring global regulatory compliance.

You may supervise regulatory staff and collaborate across functions to design department strategies, with a focus on FDA/EMA/Health Canada and ICH guidelines.)