Biologics Regulatory CMC Lead | Hybrid & AI Tools

MFS Investments; Boston (MA); Hybrid; USD 166,000 - 250,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Hybrid work

Job summary

Vertex Pharmaceuticals seeks an Associate Director, Regulatory CMC for biologics in Boston. You will lead CMC strategies, authoring and overseeing global submissions and interactions with Health Authorities.

The role emphasizes AI-enabled document preparation and a data-driven approach to ensure compliance and quality. Ideal candidates bring 8+ years in biologics regulatory affairs, deep knowledge of FDA/EMA/ICH standards, and a track record of cross-functional leadership in a global matrix.

Qualifications

• 8+ years in pharma/biotech with biologics focus.
• Experience leading CMC submissions and HA interactions.
• Ability to operate in a global matrixed environment.
• Experience applying AI-enabled regulatory capabilities.

Responsibilities

• Lead preparation, review, and lifecycle management of CMC sections of global regulatory submissions for biologics (INDs/CTAs, NDAs/BLAs/MAAs).
• Provide regulatory guidance to cross-functional teams and lead HA interactions.
• Advance AI-enabled capabilities for regulatory document preparation and review.
• Drive data-driven content and traceability in submissions.

Skills

CMC regulatory

Strategic thinking

Cross-functional leadership

Communication skills

Planning and prioritization

Regulatory submissions

Education

Bachelor’s degree in life sciences

Tools

AI regulatory tools

Job description

Vertex Pharmaceuticals seeks an Associate Director, Regulatory CMC for biologics in Boston. You will lead CMC strategies, authoring and overseeing global submissions and interactions with Health Authorities.

The role emphasizes AI-enabled document preparation and a data-driven approach to ensure compliance and quality. Ideal candidates bring 8+ years in biologics regulatory affairs, deep knowledge of FDA/EMA/ICH standards, and a track record of cross-functional leadership in a global matrix.