Job Description

Senior Director, Regulatory Transformation & Innovation

Job Summary

The Senior Director, Regulatory Transformation & Innovation is a strategic leadership role within Regulatory Operations responsible for driving the implementation of transformation initiatives across Global Regulatory Affairs (GRA). This Senior Director will define and execute a transformation and innovation strategy that modernizes GRA-related processes by enabling new ways of working through application of digitization, AI/ML, analytics, automation, and technology solutions.

Working across GRA and cross-functional partners, the Senior Director will identify, prioritize, and implement opportunities to enhance organizational effectiveness and drive business value, including through innovative approaches to regulatory document development, knowledge management, data utilization, and decision support. The role will ensure innovation efforts are grounded in GRA business needs, aligned to regulatory requirements and enterprise priorities, and focused on measurable business outcomes.

The ideal candidate will bring deep expertise in Regulatory Affairs, along with a proven track record of leading transformation, innovation, analytics, AI, or digital enablement initiatives in regulated environments. The successful candidate will serve as a trusted advisor to senior leadership, fostering a culture of innovation, continuous learning, and transformation across GRA.

This is a hybrid role requiring a minimum of three days per week onsite at our Boston (Seaport) location.

Key Responsibilities

• Develop and execute a Regulatory Transformation & Innovation strategy aligned with GRA objectives and enterprise priorities, while ensuring delivery of practical business outcomes.
• Lead strategy, design, digitization, implementation, and continuous improvement of end-to-end global regulatory affairs practices to drive value, including increased efficiencies and reduction of manual work effort (e.g., end-to-end regulatory document authoring, workflow automation, structured content development).
• Identify, prioritize, and advance emerging opportunities to enhance regulatory capabilities through innovation, AI, analytics, automation, and evolving industry practices (e.g., cloud-based regulatory submissions).
• Continuously assess external trends, regulatory innovation, and industry best practices to inform strategic priorities and capability investments.
• Lead innovative approaches to regulatory content development, knowledge management, data utilization, and decision support (e.g., structured content development).
• Partner with stakeholders to identify and implement advanced technology capabilities, which improve quality, accelerate delivery, and enhance organizational effectiveness.
• Establish governance, prioritization, and value-realization frameworks to evaluate and advance transformational opportunities across GRA.
• Collaborate across functions to align transformation initiatives with business priorities, organizational goals, and regulatory requirements.
• Build strong relationships with external partners, industry groups, and vendors to bring innovative ideas and capabilities into the organization.
• Serve as a strategic advisor to senior leaders on innovation opportunities, transformation priorities, and organizational readiness.
• Communicate progress, impact, and lessons learned across the organization to maintain transparency, momentum, and alignment.
• Define, monitor, and communicate measurable improvements in organizational effectiveness, business performance, quality, agility, and user experience.

Minimum Qualifications

• Bachelor’s degree required; advanced degree preferred.
• 10+ years of experience in Regulatory Affairs, life sciences, or other regulated industries, with a strong understanding of regulatory processes, regulatory content development, submissions management, or comparable regulated business functions.
• 10+ years of experience leading transformation, analytics, digital enablement, or strategic technology initiatives that drive measurable business impact.
• Demonstrated experience leading AI, advanced analytics, knowledge management, or digital transformation initiatives within Regulatory Affairs or other regulated functions.
• Proven ability to translate innovation strategies into operational execution and measurable outcomes by implementing advanced technologies that enhance business processes and team performance.
• Demonstrated expertise in change management, organizational transformation, and driving adoption of new capabilities and ways of working.
• Knowledge of regulatory innovation trends, structured content, data-driven regulatory approaches, and emerging industry practices.
• Exceptional leadership, communication, collaboration, and stakeholder engagement skills, with proven ability to influence senior leaders and drive alignment across cross-functional organizations.

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:

Disclosure Statement:

Flex Designation:

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 [email protected]