Regulatory Fellow

Details

Posted: 12-Apr-24

Location: Boston, Massachusetts

Type: Full-time

Salary: Open

Categories:

Academic/Faculty
Business/Finance

Internal Number: 5172002

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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About Northeastern University
Founded in 1898, Northeastern University is a private research university located in the heart of Boston. Northeastern is a leader in worldwide experiential learning, urban engagement, and interdisciplinary research that meets global and societal needs. Our broad mix of experience-based education programs?our signature cooperative education program, as well as student research, service learning, and global learning?build the connections that enable students to transform their lives. The University offers a comprehensive range of undergraduate and graduate programs leading to degrees through the doctorate in nine colleges and schools.
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