Associate Director, Regulatory CMC, Biologics

Vertex Inc.•Boston, MA

2d•$166,400 - $249,600•Hybrid

About The Position

The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and commercial products focusing on biologics. This role is accountable for authoring, reviewing, and delivering high-quality regulatory submissions, while serving as the primary CMC interface with Health Authorities. The role integrates advanced digital and AI-enabled approaches to enhance the quality, consistency, and efficiency of regulatory document preparation and review.

Requirements

Advanced knowledge of global regulatory CMC requirements (FDA, EMA, ICH, Health Canada) for biologics
Strategic thinking and problem solving
Excellent communication skills
Ability to lead and influence cross-functional teams
Strong planning and prioritization skills
Ability to work in a global matrixed environment
Commitment to quality and compliance
May include people management responsibilities
Working knowledge of AI tools for regulatory document preparation and review
Experience with structured content and data-driven authoring
Ability to critically review AI-assisted outputs
Familiarity with digital submission and data integrity expectations
Ability to identify automation and AI opportunities
Bachelor’s degree in Biology, Chemistry, Pharmacy, Regulatory Affairs, or related life science field (advanced degree preferred)
8+ years of experience in pharmaceutical or biotechnology industry with a focus on biologics
Experience leading CMC regulatory submissions and HA interactions for biologics
Experience with complex or multi-product strategies preferred

Responsibilities

Leads preparation, review, and lifecycle management of CMC sections of global regulatory submissions for biologics (INDs/CTAs, NDAs/BLAs/MAAs)
Develops and drives global CMC regulatory strategies for assigned programs
Serves as primary regulatory CMC lead for Health Authority interactions
Provides regulatory guidance to cross-functional teams
Leads regulatory assessment of CMC changes, deviations, and investigations
Applies AI-enabled tools for authoring, review, and consistency checks
Drives structured content and data traceability approaches
Supports AI/digital capability development
Contributes to process improvements and innovation initiatives
Represents Regulatory CMC in governance forums
Stays abreast of and adopts emerging technologies, including AI, and maintains a continuous learning mindset to strengthen regulatory CMC's decision-making and innovation.
Proactively remains up to date on advances in technology, AI, automation, competitive intelligence, and changes in the regulatory environment.