Senior Director, Regulatory Transformation & Innovation

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.

Pay Range

Pay Range: $216,300 - $324,500 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.

Benefits

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.

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 View email address on click.appcast.io.

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 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.