Director, Regulatory Affairs CMC

Vertex Inc.•Boston, MA

4d•$190,400 - $285,600•Hybrid

About The Position

The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible for developing and executing global regulatory strategies across multiple investigational and commercial products in the small molecule portfolio. This role provides strategic leadership for complex regulatory CMC activities, oversees Health Authority engagement, and ensures regulatory requirements are effectively integrated into development and commercialization plans. The Director drives organizational excellence through talent development, process innovation, and the application of digital and AI-enabled capabilities to enhance the quality, consistency, and efficiency of regulatory decision-making, document preparation, and submission execution.

Requirements

Comprehensive knowledge of FDA, EMA, Health Canada, ICH, and global CMC requirements.
Advanced strategic thinking and regulatory risk assessment skills.
Exceptional communication, negotiation, and leadership skills.
Ability to influence senior leaders and governance committees.
Strong organizational and resource planning capabilities.
Proven ability to build and develop high-performing teams.
Knowledge of digital regulatory trends, structured content, data governance, and AI applications.
Ability to establish governance and controls for AI-enabled regulatory processes.
Experience leveraging AI-enabled tools for dossier preparation, content development, review, and knowledge management.
Ability to evaluate and oversee AI-generated regulatory content.
Bachelor’s Degree in Chemistry, Biology, Pharmacy, Regulatory Affairs, Pharmaceutical Sciences, Engineering, or related life sciences discipline.
10+ years of pharmaceutical, biotechnology, or related industry experience supporting small molecule development.
3+ years of people management experience leading technical and/or regulatory professionals.
Experience developing and executing global CMC regulatory strategies.
Experience leading major submissions and Health Authority interactions.
Experience driving organizational change and process improvements.
Demonstrated leadership in global matrix organizations.
May have budgetary and direct people-management accountability.
Commitment to innovation, continuous improvement, and operational excellence.

Nice To Haves

Advanced degree (M.S., Pharm.D., or Ph.D.) preferred.
Experience implementing technology-enabled process improvements in regulated environments preferred.

Responsibilities

Leads development and execution of global CMC regulatory strategies for multiple investigational and marketed products in the small molecule portfolio.
Oversees preparation, review, and approval of CMC content for global regulatory submissions.
Provides strategic leadership for Health Authority interactions and negotiations.
Leads and develops Regulatory CMC staff through coaching and talent development.
Ensures consistent regulatory guidance to cross-functional stakeholders.
Serves as senior Regulatory CMC representative on governance bodies and product teams.
Identifies regulatory risks and develops mitigation strategies.
Drives continuous improvement through structured content and digital regulatory capabilities.
Champions AI-enabled technologies for authoring, review, data traceability, and knowledge management.
Ensures programs are appropriately resourced and accountable for regulatory milestones.
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.