Director, Regulatory Affairs CMC

Vertex Pharmaceuticals Inc (US); United States; Hybrid; USD 190,000 - 286,000; Full time

Benefits offered by this job

Hybrid-Eligible

On-Site Eligible

Annual bonus

Job summary

Vertex Pharmaceuticals Inc. is seeking a Director of Chemistry Manufacturing Controls (CMC) to lead a global Regulatory CMC team and shape regulatory strategies for small molecule programs.

The role drives leadership, process innovation, and AI-enabled capabilities to improve decision-making, documentation, and submissions across investigational and commercial products. The ideal candidate brings 10+ years in pharma/biotech, advanced regulatory knowledge, and a track record of cross-functional

Qualifications

• Bachelor’s degree in Chemistry, Biology, Pharmacy, Regulatory Affairs, Pharmaceutical Sciences, Engineering or related field.
• Advanced degree (M.S., Pharm.D., or Ph.D.) preferred.
• 10+ years in pharma/biotech with small molecule experience.

Responsibilities

• Lead global regulatory CMC strategies for multiple products (investigational and marketed).
• Oversee CMC submissions content development, review, and approval.
• Provide leadership in Health Authority interactions and negotiations.
• Develop Regulatory CMC staff through coaching and talent development.
• Ensure consistent guidance to cross-functional stakeholders across programs.
• Represent Regulatory CMC on governance bodies and product teams.

Skills

Regulatory leadership

Strategic thinking

Communication & negotiation

Leadership of teams

AI in regulatory

Regulatory risk assessment

Digital/regulatory trends

Influencing senior leaders

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Tools

AI-enabled regulatory tools

Dossier automation tools

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.

Company Description

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Pay Range and Disclosure Statement

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.

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 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.

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 [e-mail].

Help Us Achieve Our Mission

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, acute pain and acromegaly, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, congenital adrenal hyperplasia, ACTH-dependent Cushing's syndrome, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 16 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube, and X. We believe our culture is one of Vertex’s greatest strengths and a key enabler of our ability to deliver transformative medicines for patients who need them. Rooted in innovation, purpose and collaboration, our culture empowers people to take smart risks, challenge conventional thinking and do their best work. The diversity of our people is central to that culture. By bringing together individuals with different backgrounds, experiences and perspectives, we foster an environment where new ideas thrive, better decisions are made and breakthrough innovation is possible. We are committed to creating a workplace where everyone feels valued, included and connected to our shared mission, because we know that our unique culture and the collective strength of our people are what set Vertex apart.