Job Description General Summary: The Regulatory Labeling Director will lead the strategic development of global labeling on one or more marketed products. This role will be responsible for the development and maintenance of global product labeling across a therapeutic area. This will include target labeling profiles (TLP), company core datasheets (CCDS) and local labeling (prescribing information, patient information) for major markets. This role will be accountable for specific labeling business processes. Key
Duties
and
Responsibilities
Ensures compliance with labeling governance requirements and associated business processes. Leads label working groups (LWG) and represents labeling at product-specific global regulatory teams and senior labeling governance meetings: Label Review Group (LRG) and Executive Label Review Group (ELRG). Plan and lead development and maintenance of global product labeling for one or more products. This includes the Company Core Data Sheets (CCDS) and regional labeling (Prescribing Information [PI], Patient Information [PIL], Instructions For Use [IFU]) for select markets (e.g., US, EU, GB, CA). Lead labeling strategy with expert ability to advise stakeholders of regulatory labeling requirements and provide oversight of health authority interactions (responses to questions, negotiations, and inspections) regarding all aspects of labeling. Conducts research related to labeling precedent, regulations, policies, and other topics as necessary to properly advise on potential labeling impacts, strategies, or outcomes. May lead one or more therapeutic areas and be responsible for the strategic development and lifecycle management of labeling for that/those area(s), including TLPs. Knowledge and Skills:
Experience
leading labeling development and regulator negotiation activities for an initial marketing application or major indication expansion. Ability to synthesize complex concepts and actions into simple and clear messaging; communicating at all levels of the organization, from specialized experts to executive management. Specialized depth of knowledge regarding labeling requirements globally, including development and life-cycle management of CCDS and of global regulatory authorities, including the FDA, EMA, and may include other authorities such as Health Canada, TGA. Advanced ability to develop, use, and apply knowledge of frameworks specific to regulatory labeling, and to use this information to support regulatory responsibilities that align with business objectives. Advanced ability to plan, prioritize, lead, and execute individual work, teamwork, and projects related to regulatory labeling in a systematic and efficient manner. Strong attention to detail with a quality-driven mindset. Strong understanding of the compliance and operational requirements for labeling. Demonstrates the ability to effectively adopt and leverage emerging technologies, including structured content management for labeling, AI-driven tools, and eLabeling technologies. Maintains a continuous learning mindset to strengthen Regulatory Labeling decision-making and operational efficiency. Proactively remains up to date on advances in technology, AI, automation, competitive intelligence and changes in the Regulatory environment.
Education
and
Experience
Bachelor’s degree Typically requires 10 years of experience in regulatory affairs in the area of global labeling or related discipline, or the equivalent combination of education and experience. *LI-EE1
Pay Range
$185,600 - $278,400 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: Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be designated as: 1. Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select 2. Hybrid: work remotely up to two days per week; or select 3. 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-Remote 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.