Remote Global Regulatory Affairs Fellow - 2-Year Program

Northeastern University; United States; Remote; USD 60,000 - 85,000; Full time

Job summary

Northeastern University Pharmaceutical Industry Fellowships Program invites Pharm.D. graduates to a two-year Global Regulatory Affairs fellowship based remotely.

Fellows will gain hands-on experience in regulatory strategy, submissions, labeling, and cross-functional collaboration with industry partners, while engaging with our faculty for professional development. The program includes a 6-month rotation in Commercial Regulatory, exposure to advertising compliance, and ongoing mentorship to

Qualifications

• PharmD degree from ACPE-accredited institution.
• Eligible for Massachusetts pharmacist licensure.
• Excellent oral and written communication skills.
• Strong time management and leadership abilities.
• Ability to work independently and take initiative on multiple projects at the industry site and Northeastern.

Responsibilities

• Regulatory submissions support for INDs, CTAs, NDAs/BLAs and other regulatory documents.
• Maintain Investigator’s Brochure, protocols, ICFs, and product labeling (US/EU).
• Collaborate with Clinical Development, Drug Safety, CMC and other functions for regulatory input.
• Review promotional materials for regulatory compliance and participate in PRC/MLR processes.
• Monitor FDA/EMA/ICH developments and support inspection readiness and process improvements.
• Develop leadership and communication skills through mentorship and professional activities.

Skills

Excellent communication

Time management

Leadership abilities

Independent work

Education

Doctor of Pharmacy degree (ACPE-accredited)

Massachusetts pharmacist licensure eligibility

Job description

Northeastern University Pharmaceutical Industry Fellowships Program invites Pharm.D. graduates to a two-year Global Regulatory Affairs fellowship based remotely.

Fellows will gain hands-on experience in regulatory strategy, submissions, labeling, and cross-functional collaboration with industry partners, while engaging with our faculty for professional development. The program includes a 6-month rotation in Commercial Regulatory, exposure to advertising compliance, and ongoing mentorship to