Regulatory Fellow

Northeastern University•Newton, MA

5d•Onsite

About The Position

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.

Requirements

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

Responsibilities

Manage, develop, and implement regulatory strategy in support of Vertex products and development programs.
Provide strategic input and tactical support to expedite the development, submission, and regulatory approval of new drug or biologic products.
Keep abreast of current legislation, guidelines, and other regulatory intelligence.