Job Details

Regulatory Fellow

Position Number: 6855615
Location: Boston, MA
Position Type: Medicine - Other Medicine

Regulatory Fellow

About the Opportunity

Vertex, in collaboration with Northeastern University, is offering a one-year Global Regulatory Affairs (GRA) PhD Fellowship at our corporate headquarters in Boston, Massachusetts.

The Regulatory PhD Fellow(s) will be responsible for regulatory support for development programs or marketed products. Fellow(s) will have an opportunity to work in Regulatory Strategy or Regulatory Chemistry, Manufacturing and Controls (CMC) and gain specialized experience in the development of regional or global regulatory strategies for development and commercialization of program(s) within the portfolio.

Key Duties and Responsibilities:

Regulatory Strategy

Contributes to the development and implementation of regulatory strategy for assigned region as a member of the Global Regulatory Affairs functional team

Develops proficiency in regional and global regulatory skills

Supports global regulatory strategy under guidance of the Global Regulatory Lead

Supports regulatory communications with local health authority; under supervision, may support regulatory interactions with the health authority

Identifies regulatory requirements for development and approval pathways for assigned region

Under supervision, manages the process for preparation, submission, and approval of regulatory applications within assigned region

Provides technical regulatory input for key product development or registration documents

Works to ensure compliance of regulatory submissions with current regulations and guidance

Reviews regulatory intelligence and guidance information to continuously support regulatory strategy in assigned region

Informs regulatory affairs senior management on the status of regulatory strategies and tactics, procedures and practices

Regulatory CMC

Contributes to the development and implementation of regulatory CMC strategy for assigned region as a member of the Global Regulatory Affairs functional team

Develops proficiency in regional and global regulatory skills

Supports global regulatory CMC strategy under guidance of the CMC Regulatory Lead

Responsible for regulatory communications with local health authority; under supervision, may support regulatory interactions with the health authority

Under supervision, manages the process for preparation, submission, and approval of CMC sections of regulatory submissions within assigned region

Provides regulatory CMC guidance to cross-functional teams and key stakeholders

Works to ensure compliance of regulatory CMC submissions with current regulations and guidance

Reviews regulatory intelligence and guidance information to continuously support regulatory CMC strategy in assigned region

Informs regulatory affairs senior management on the status of regulatory strategies and tactics, procedures and practices

Required Experience:

You may be a fit for our fellowship program if the following describes you:

Successfully completed a Doctoral program in a scientific background within the last two years

Understanding of drug development and related concepts, such as clinical trial design, statistics, and clinical pharmacology.

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 July at our corporate office in Boston.

This position is Hybrid-Eligible or On-Site Eligible

In this Hybrid-Eligible role, you can choose to be designated as:

1. Hybrid: work remotely up to two days per week; or select

2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

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:
$76,335.00 - $107,823.75

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.

To apply, visit https://northeastern.wd1.myworkdayjobs.com/en-US/careers/job/Boston-MA-Main-Campus/Regulatory-Fellow_R138347