Regulatory Fellow

Northeastern University•Boston, MA

5d•$76,335 - $107,824•Hybrid

About The Position

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.

Requirements

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.

Responsibilities

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