Job Description The Director, Global Regulatory Affairs Process Excellence & Transformation leads complex, cross-functional operational excellence initiatives across Global Regulatory Affairs (GRA). The role is responsible for identifying, designing, and implementing process improvements that enhance efficiency, consistency, and quality across GRA processes. As a key member of the GRA Process Optimization Network (GPON), this role consults with cross-team representatives to diagnose operational challenges and deliver scalable, sustainable solutions. The Director applies deep subject-matter expertise and hands-on operational excellence experience to shape objectives and drive transformation aligned with GRA and corporate goals. This is a Boston based, hybrid position requiring 3 days/week onsite. Key
Duties
&
Responsibilities
Lead complex GRA process improvement and transformation initiatives using structured operational excellence methodologies. Drive cross-functional consultation through GPON and partner with GRA sub-functions to identify, prioritize, and solve critical business process challenges. Define, standardize, and optimize end-to-end GRA processes, ensuring clarity, scalability, and alignment with organizational requirements. Facilitate process mapping, root-cause analysis, scenario planning, and solution development activities across GRA. Develop and implement change management plans, training, communication, and adoption strategies to ensure sustainable process implementation Partner with governance forums and senior leaders to ensure process improvements support GRA operational needs and corporate priorities. Create, maintain, and enhance process documentation including playbooks, workflows, templates, and RACIs. Establish performance metrics, dashboards, and reporting to measure process health, adoption, and continuous improvement opportunities. Collaborate across GRA, Program Leadership, and adjacent functions to ensure optimized processes integrate effectively across the development continuum. Provide operational excellence coaching and capability building across GRA teams to strengthen process maturity and execution efficiency. Knowledge and Skills: Advanced knowledge of operational excellence methodologies and practical application of tools such as process mapping, root-cause analysis, value-stream mapping, and KPI development. Strong expertise in developing and implementing process improvements across cross-functional teams. Excellent written and oral communication skills, including the ability to facilitate workshops and present complex information to senior leaders. Strong collaboration skills to effectively interact with internal and external stakeholders at all levels. Ability to influence and drive alignment without formal authority. Organizational skills and ability to manage multiple priorities. Knowledge of regulatory processes, systems, and requirements is preferred.
Experience
with digital workflow tools or process automation is a plus. Ability to drive firm deadlines.
Education
and
Experience
Minimally requires a Bachelor's degree in Life Sciences or a related field; an advanced degree is preferred. 10 years of experience or the equivalent combination of education and experience.
Experience
within the Life Sciences industry or similar. Hands-on experience applying operational excellence methodologies (e.g., Lean, Six Sigma, Kaizen) to deliver measurable process improvements.
Experience
leading large, complex, cross-functional process optimization efforts in a global or matrixed environment.
Experience
working with regulatory processes strongly preferred. #LI-EE1 #LI-Hybrid
Pay Range
$184,800 - $277,200 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. 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 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. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. 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 APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is 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 14 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 Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.