Job Description
The Director is responsible for overseeing the development and implementation of global regulatory CMC strategies for assigned cell and/or gene therapy products, including combination products with devices. The Director will provide strategic and operational leadership for regulatory CMC activities including submissions, reviews, and health authority interactions.
Key Responsibilities
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Design, develop, and implement regulatory CMC strategy for assigned cell and/or gene therapy projects
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Work collaboratively across functions and teams to develop and implement regulatory CMC strategies
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Develop and maintain relationships with health authorities and lead the preparation of health authority interactions
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Develop regulatory strategies integrated with cross-functional project teams to facilitate timely submissions and approvals
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Provide regulatory expertise and serve as internal consultant on relevant global regulations and guidelines, current regulatory environment and regulatory precedent
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Develop/assess project plans and timelines and assign and manage team effectively to ensure projects are appropriately prioritized and goals are met
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Recognized internally and externally as an expert in cell and gene therapy regulations, guidelines and precedents related to pharmaceutical development
Minimum Qualifications
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Advanced degree in a scientific discipline (PhD preferred; Masters acceptable with experience)
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8+ years of pharmaceutical industry experience
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6+ years of experience working in related regulatory affairs CMC
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Experience in cell and/or gene therapy and device experience preferred
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Proficiency in regulatory (FDA, EMA, Health Canada, ICH) guidelines
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Experience in leading CMC submission preparation and Health Authority interactions, BLA/MAA preparation and filing experience a plus
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Strategic thinking and strong problem-solving skills
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Strong interpersonal skills and the ability to communicate effectively cross-functionally
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Strong oral and written communication skills
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Sound understanding of CMC and GMP related issues.
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Strong sense of planning and prioritization, and the ability to work with all levels of management
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Proven ability to work with interdisciplinary teams and dealing with unfamiliar situations
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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.
