Regulatory Fellow

About the Opportunity This job description is intended to describe the general nature and level of work being performed by people assigned to this classification. It is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. JOB SUMMARY Northeastern is offering a one-year PhD Fellowship in our Global Regulatory Affairs (GRA) Team at our corporate headquarters in Boston, Massachusetts. The PhD fellow(s) will have an opportunity to gain specialized and in-depth regulatory expertise of the requirements for the development and approval of new pharmaceutical products. The PhD fellows will work closely with regulatory leaders at Vertex to support future submissions to the U.S. Food and Drug Administration (FDA), such Investigational New Drug Applications (INDs) and Biologic Licensing Applications (BLAs)/New Drug Applications (NDAs), and other Regulatory Health Authorities. During the fellowship there will be the opportunity to be involved with the creations of the key documents supporting the submission, preparing for and participating in health authority interactions, and responding to questions raised by the FDA during their review. MINIMUM QUALIFICATIONS You may be a fit for our fellowship program if the following describes you: Successfully completed a Doctoral program and thesis defense in a scientific background Ability to assess and understand complex scientific information Strong problem-solving skills Strong written and verbal communication skills to exchange complex information with others in complex situations Ability to work effectively within a team environment Ability to plan, prioritize, and contribute to work and projects in a systematic and efficient manner Ability to start in May at our corporate office in Boston KEY RESPONSIBILITIES & ACCOUNTABILITIES Regulatory Strategy Development 50% Manage, develop, and implement regulatory strategy in support of Vertex products and development programs. Regulatory Approval Support 30% Provide strategic input and tactical support to expedite the development, submission, and regulatory approval of new drug or biologic products. Regulatory Intelligence 20% Keep abreast of current legislation, guidelines, and other regulatory intelligence. Position Type Legal and Regulatory Administration Additional Information Northeastern University considers factors such as candidate work experience, education and skills when extending an offer. Northeastern has a comprehensive benefits package for benefit eligible employees. This includes medical, vision, dental, paid time off, tuition assistance, wellness & life, retirement- as well as commuting & transportation. Visit https://hr.northeastern.edu/benefits/ for more information. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, religion, color, national origin, age, sex, sexual orientation, disability status, or any other characteristic protected by applicable law. Compensation Grade/Pay Type: 110S Expected Hiring Range: $75,210.00 - $106,230.00 With the pay range(s) shown above, the starting salary will depend on several factors, which may include your education, experience, location, knowledge and expertise, and skills as well as a pay comparison to similarly-situated employees already in the role. Salary ranges are reviewed regularly and are subject to change. Founded in 1898, Northeastern is a global research university and the recognized leader in experiential lifelong learning. Our approach of integrating real-world experience with education, research, and innovation empowers our students, faculty, alumni, and partners to create worldwide impact. Our global university system provides our community and academic, government, and industry partners with unique opportunities to think locally and act globally. The systemwhich includes 14 campuses across the U.S., U.K., and Canada, 300,000-plus alumni, and 3,000 partners worldwideserves as a platform for scaling ideas, talent, and solutions. The universitys residential campuses for undergraduate and graduate degrees are located in Boston, London, and Oakland, California. Our research and graduate campuses are in the Massachusetts communities of Burlington and Nahant; Arlington, Virginia; Charlotte, North Carolina; Miami; Portland, Maine; Seattle; Silicon Valley, California; Toronto; and Vancouver. Northeasterns personalized, experiential undergraduate and graduate programs lead to degrees through the doctorate in 10 colleges and schools across our campuses. Learning emphasizes the intersection of data, technology, and human literacies, uniquely preparing graduates for careers of the future and lives of fulfillment and accomplishment. Our research enterprise, with an R1 Carnegie classification, is solutions oriented and spans the world. Our faculty scholars and students work in teams that cross not just disciplines, but also sectorsaligned around solving todays highly interconnected global challenges and focused on transformative impact for humankind.