Job DescriptionGeneral Summary:The Senior Director, Regulatory Labeling is a regulatory labeling leader with expert technical and operational experience in regulatory labeling globally. This role is responsible for overseeing the development and maintenance of global product labeling for marketed products, as well as pipeline activities for the cystic fibrosis (CF) portfolio. This includes target labeling profiles, company core datasheets, and local labeling (prescribing information and patient information). The role is accountable for business processes specific to the management of marketed product labeling.Key Duties and Responsibilities:Holds primary responsibility for the development of product labeling, including core labels and local US and EU labeling, to support CF drug development and all product lifecycle management.Leads a team of Global Labeling Leads (GLLs) responsible for day-to-day labeling activities. Manages team resourcing and product assignments.Accountable for compliance with health authority requirements, labeling governance requirements, and associated business processes.Chairs the marketed product Label Review Group(s) (LRGs) and represents labeling at senior labeling governance meetings (ELRG).Leads marketed product and cystic fibrosis labeling strategy, including development, management, and maintenance of product labeling for the lifecycle of assigned products.Challenges the team to provide complete, robust, and clear rationale for labeling changes.Advises stakeholders of regulatory labeling requirements for quality, preclinical, and clinical data.Provides oversight of health authority interactions regarding all aspects of labeling across a therapeutic area, including responses to questions, negotiations, and inspections.Identifies opportunities for improvement and leads initiatives, working with cross-functional stakeholders to ensure compliant and efficient operations within the marketed product labeling team.Is part of the Labeling Leadership team and works collaboratively with peers to ensure overall Global Labeling team effectiveness.Provides department/company training on labeling practices and policies.Knowledge and Skills:A business-minded leader, capable of strategic thinking and proposing innovative solutions to problems.Demonstrates excellent communication skills with the ability to impact and influence the decisions of a team.Communicates clearly and effectively with all levels within the company and acts as a liaison/representative of labeling both internally and externally.Expert-level knowledge regarding labeling requirements globally, including development and life-cycle management of TLPs, CCDS, and familiarity with global regulatory authorities including the FDA and EMA.Expert ability to develop, use, and apply knowledge of frameworks specific to regulatory global and regional labeling, and to support regulatory responsibilities that align with business objectives.Excellent organizational, analytical, problem-solving, proofreading, and decision-making skills.Ability to articulate the organization’s strategic vision and core values and contribute to improving the quality of internal regulatory labeling policies, programs, and initiatives.A strong leader who demonstrates sensitivity and understanding of others' perspectives and continuously develops staff by providing feedback, coaching, guidance, and mentoring.Education and Experience:Typically requires 12 years of relevant pharmaceutical or biotech industry experience within regulatory affairs and 5 years of supervisory/management experience, or the equivalent combination of education and experience.Pay Range:$220,000 - $330,000Disclosure 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.Flex Designation:Remote-EligibleCompany Information:Vertex is a global biotechnology company that invests in scientific innovation and 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.

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