Remote Global Regulatory Affairs Fellow (PharmD)

NU USA Northeastern University; Boston (MA); Remote; USD 60.000 - 85.000; Vollzeit

Benefits dieser Stelle

Medical insurance

Tuition assistance

Paid time off

Retirement plan

Wellness program

Commuting & transportation

Zusammenfassung

Northeastern University invites Pharm.D. graduates to join a two-year Global Regulatory Affairs fellowship offered in partnership with Dompé.

The program combines hands-on drug development and regulatory strategy with collaboration across Clinical, Safety and CMC teams, while rotating through Commercial Regulatory activities. Based remotely, the fellowship supports professional development through seminars, teaching, and leadership opportunities, and culminates with experience in global

Qualifikationen

• PharmD degree from an ACPE-accredited institution
• Eligible for pharmacist licensure in the State of Massachusetts
• Excellent oral and written communication skills
• Strong time management and leadership abilities
• Ability to work independently and take initiative on various projects

Aufgaben

• Gain hands-on training in global drug development and regulatory strategy with cross-functional teams
• Support regulatory submissions including INDs, CTAs, NDAs/BLAs and Health Authority interactions
• Assist labeling and core documentation to global product labeling, including CCDS, USPI, and EU SmPC
• Collaborate with Clinical Development, Drug Safety, CMC and other functions to provide regulatory input
• Review promotional materials for regulatory compliance in PRC/MLR processes
• Monitor evolving FDA/EMA/ICH requirements and support inspection readiness
• Engage in professional development through seminars, teaching, and mentorship

Kenntnisse

Communication skills

Time management

Leadership abilities

Independent work

Ausbildung

Doctor of Pharmacy (PharmD)

Jobbeschreibung

Northeastern University invites Pharm.D. graduates to join a two-year Global Regulatory Affairs fellowship offered in partnership with Dompé.

The program combines hands-on drug development and regulatory strategy with collaboration across Clinical, Safety and CMC teams, while rotating through Commercial Regulatory activities. Based remotely, the fellowship supports professional development through seminars, teaching, and leadership opportunities, and culminates with experience in global