Global Regulatory Affairs Postdoctoral Research Fellow

About the role

The Global Regulatory Affairs Postdoctoral Research Fellow is a two‑year, remote fellowship jointly offered by Dompé and Northeastern University. The fellow will receive hands‑on training in global drug development, regulatory strategy, and commercial regulatory affairs.

Key responsibilities

• Support preparation and submission of INDs, CTAs, NDAs/BLAs, orphan drug applications, pediatric plans, and related regulatory documents.
• Collaborate with Clinical Development, Drug Safety, CMC, and other cross‑functional teams to ensure regulatory alignment.
• Participate in FDA, EMA, and PMDA meetings and respond to health‑authority queries.
• Complete a 6‑month rotation in Commercial Regulatory Affairs, reviewing promotional materials for compliance.

Required profile

• Doctor of Pharmacy degree from an ACPE‑accredited institution.
• Eligibility for pharmacist licensure in Massachusetts.
• Strong oral and written communication, time‑management, and leadership abilities.

Required skills

• Knowledge of regulatory submissions (IND, NDA, BLA, CTA, orphan drug, pediatric plans).
• Familiarity with labeling documents such as Investigator’s Brochure, USPI, EU SmPC.

What we offer

• Comprehensive benefits package including medical, vision, dental, paid time off, tuition assistance, wellness and life insurance, retirement plans, and commuting assistance.
• Professional development through academic seminars, research, teaching, conferences, and mentorship.