Regulatory Fellowship at Northeastern University

Founded in 1898, Northeastern is a global research university and the recognized leader in experiential lifelong learning. Our approach of integrating real-world experience with education, research, and innovation empowers our students, faculty, alumni, and partners to create worldwide impact.

Post : Regulatory Fellow

Job Description
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

Candidate Profile
• 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.

Additional Information
Qualification : Doctoral program in a scientific background
Location : Boston, MA (Main Campus)
Industry Type : Pharma/ Healthcare/ Clinical research
Job ID : R138347
Position Type : Legal and Regulatory Administration
Expected Hiring Range : USD 76,335.00 - USD 107,823.75
End Date : 31st March 2026