Remote Global Regulatory Affairs Fellow – PharmD

Northeastern University; Boston (MA); Hybrid; USD 60,000 - 85,000; Full time

Benefits offered by this job

Comprehensive benefits

Job summary

Northeastern University invites applications for a two-year Global Regulatory Affairs fellowship, conducted remotely in partnership with Dompé. The Pharm.D. graduate will gain hands-on training in global drug development, IND/CTA/NDA submissions, labeling, and health authority interactions with cross-functional teams.

The program emphasizes regulatory strategy, cross-functional collaboration, and professional development within a dynamic regulatory environment in the biopharmaceutical industry.

Qualifications

• Excellent oral and written communication skills.
• Strong time management and leadership abilities.
• Ability to work independently and take initiative on a variety of projects.

Responsibilities

• Support regulatory submissions (INDs, CTAs, NDAs/BLAs) and health authority interactions.
• Assist labeling and core documentation development (Brochure, USPI, SmPC).
• Collaborate with Clinical Development, Drug Safety, and CMC teams.
• Review promotional materials for regulatory compliance and PRC/MLR processes.
• Monitor evolving FDA/EMA/ICH requirements and inspection readiness.
• Engage in professional development and leadership activities.

Skills

Excellent communication

Time management

Leadership

Independent working

Education

Doctor of Pharmacy (PharmD)

Job description

Northeastern University invites applications for a two-year Global Regulatory Affairs fellowship, conducted remotely in partnership with Dompé. The Pharm.D. graduate will gain hands-on training in global drug development, IND/CTA/NDA submissions, labeling, and health authority interactions with cross-functional teams.

The program emphasizes regulatory strategy, cross-functional collaboration, and professional development within a dynamic regulatory environment in the biopharmaceutical industry.