Regulatory Fellow

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.
  
  Northeastern University is an equal opportunity employer, seeking to recruit and support a broadly diverse community of faculty and staff. Northeastern values and celebrates diversity in all its forms and strives to foster an inclusive culture built on respect that affirms inter-group relations and builds cohesion.
  
  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.
  
  To learn more about Northeastern University's commitment and support of diversity and inclusion, please see www.northeastern.edu/diversity.
  
  
  To apply, visit https://northeastern.wd1.myworkdayjobs.com/en-US/careers/job/Boston-MA-Main-Campus/Regulatory-Fellow_R119573
  
  
  
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