Director, Regulatory Affairs CMC

Job Description

General Summary:

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.

Key Duties and 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.

Knowledge and Skills:

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.

Experience implementing technology-enabled process improvements in regulated environments preferred.

Education and Experience:

Bachelor’s Degree in Chemistry, Biology, Pharmacy, Regulatory Affairs, Pharmaceutical Sciences, Engineering, or related life sciences discipline. Advanced degree (M.S., Pharm.D., or Ph.D.) preferred.

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.

*LI-EE1 *LI-Hybrid

Pay Range:

$190,400 - $285,600

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.  From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:

1.    Hybrid: work remotely up to two days per week; or select

2.    On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com