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

Additional Information

Northeastern University considers factors such as candidate work experience, education and skills when extending an offer.  

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:

Expected Hiring Range:

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.