Hiring: Director, Regulatory Labeling Strategy (Remote-Eligible) Company: Vertex Pharmaceuticals Location: Boston, MA Job Posted Time: 2026-09-10 11:47:33 Employment Type: Remote About the job Experience: •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. Required Skills: •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. •Demonstrated capacity 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. Qualifications: •Bachelor’s degree Compensation: •$185,600 - $278,400 / year •Flexible work environment (work from home / hybrid options) •This role is eligible for an annual bonus and annual equity awards Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!