Senior Manager, Regulatory Affairs - Strategy
The Sr. Manager is responsible for developing and implementing innovative regulatory strategies in support of various projects and sub-teams. As a Regional Regulatory Lead, the Sr. Manager is responsible for planning and coordinating all aspects of regulatory submissions necessary to support clinical trials, product registration and life cycle management in their region and is the main point of contact for Regulatory Authorities for an assigned project.
• Responsible for specified regulatory deliverables for multiple development programs, working with the Global Regulatory Lead, cross-functional stakeholders and consultant(s), as needed
• Represent GRA on cross-functional teams, such as study execution teams, clinical development task-forces and commercial sub-teams, as the regulatory subject matter expert for that region
• Develop, drive and coordinate regulatory timelines, working closely with the Global Regulatory Lead and other key stakeholders
• Work with the Global and Regional Labeling Lead to support the development of the regional labeling strategy
• Prepare, review and/or approve regulatory submission documents and regulatory authority communications
• As the Regional Regulatory Lead, serve as the main point of contact with regulatory authorities, and lead region-specific regulatory authority interactions
• Ensure compliance of regulatory strategies and submissions with current regulations and guidance
• May serve as point of contact with contractors and corporate partners, where relevant, for specific projects
• Contribute to the continuous improvement of existing department processes and strategies, providing recommendations in their area of expertise
• Bachelor’s degree in relevant scientific discipline, higher degree desirable
• Ph.D. (or equivalent degree) and 4+ years of relevant work experience, or
• M.S. (or equivalent degree) and 6+ years of relevant work experience, or
• B.S. (or equivalent degree) and 8+ years of relevant work experience
• Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance – preferably from at least both US and EU
• Regulatory knowledge in a number of therapeutic areas and with drug-device combination products
• Ability to effectively collaborate with internal and cross functional colleagues at all levels of the organization to achieve business objectives
• Strong written and oral communication, listening, and non-verbal communication skills
• Able to provide regulatory leadership on a cross-functional team and work effectively in a matrix environment
• Capable of strategic thinking and proposing innovative solutions to regulatory problems
• Advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to drug development
• Actively pursues innovation and excellence and is able to motivate others to pursue these values.
• Capable of leading significant general projects for the function, including due diligence activities
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases.
Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and offices around the world. For several consecutive years, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the Company, please visit www.vrtx.com.
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.