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Regulatory Affairs for Medical Devices, Pharmaceuticals & Biologics

RA 101
Closed
Northeastern University
Northeastern University
Boston, Massachusetts, United States
CH
Cara Halloran - Paquette
Partnership Development Coodinator
(7)
6
General
  • Graduate
  • 80 learners; teams of 5
  • 40 hours per learner
  • Dates set by experience
  • Learners self-assign
Preferred companies
  • 1/10 project matches
  • Anywhere
  • Academic experience
  • Any
  • Any
Categories
General Communications Operations Market expansion Product or service launch Sales strategy
Skills
regulatory affairs marketing medical devices regulatory sciences pharmaceuticals research commercialization
Project timeline
  • January 23, 2023
    Experience start
  • January 25, 2023
    Project Scope Meeting
  • April 1, 2023
    Experience end
Overview
Details

A global, experiential, research university is seeking projects for their Master of Science in Regulatory Affairs capstone course. The Master of Science in Regulatory Affairs program is designed to both broaden and deepen the student’s understanding of current global compliance requirements and their practical application in the design, development, approval, and post marketing of products utilized within regulated industries.

The capstone course challenges students to exercise their ability to translate global regulatory requirements for globally regulated product commercialization into submission-ready documents and broadly applicable regulatory science solutions.

This is your opportunity to connect with students and faculty from a renowned institution in New England that consistently ranks among the top universities in the United States and is known for its focus on interdisciplinary education, extensive research output, and collaborative student culture.

Learner skills
Regulatory affairs, Marketing, Medical devices, Regulatory sciences, Pharmaceuticals, Research, Commercialization
Deliverables

Deliverables are negotiable, and will seek to align the needs of the students and the organization.

Some final project deliverables might include:

  1. A 10-15 minute presentation on key findings and recommendations
  2. A detailed report including their research, analysis, insights and recommendations
Project Examples

Student teams will work with your organization to identify your needs and provide actionable recommendations, based on in-depth research and analysis.

Desired project topics include:

Strategic Regulatory Affairs

  • Classification
  • Combination Product Approvals
  • Global Commercialization

Clinical Research

  • Clinical Trial Design
  • Clinical Operations
  • Study Rationales

Regulatory Compliance

  • Adverse event profiling
  • REMS
  • Post Market Surveillance

General Regulatory Affairs

  • Regulatory Market Research

We invite you to share your projects for consideration. Please include an executive summary of the regulatory affairs problem or topic. Be sure to include a brief description of your organization and mission.

We are also seeking projects for many other academic domains including, Communications, Marketing, Public Policy and General Business. Please reach out for more details!

Additional company criteria

Companies must answer the following questions to submit a match request to this experience:

A representative of the company will be available for a pre-selection discussion with the administrator of the course to review the project scope.

A representative of the company will be available to answer questions from students in a timely manner for the duration of the project.