Dompe- Global Regulatory Affairs Postdoctoral Research Fellow

Northeastern University•Boston, MA

12d•Remote

About The Position

Northeastern University Pharmaceutical Industry Fellowships Program is a two-year experiential program designed to advance lifelong learning and the education and training of Pharm.D. graduates. A key element of the program’s success is preparing Fellows to meet evolving workforce needs across various sectors of the pharmaceutical industry. Fellows have the opportunity to work closely with our innovative biopharmaceutical industry partners, while engaging with Northeastern University faculty in professional and career development, teaching, service, and scholarly activities. In partnership with Northeastern University, Dompé is offering a two-year Global Regulatory Affairs fellowship, based remotely. Dompé is an Italian bio-pharmaceutical company that focuses on innovation, where a long tradition in the field of personal wellness goes hand-in-hand with a commitment to research and development to meet unsatisfied therapeutic needs. Established in 1940 in Milan, Dompé has an industrial and biotech research hub in L’Aquila, in addition to branches in Europe (Barcelona, Berlin, Paris and Tirana). The company has approximately 1000 employees. The US headquarters of Dompé are based in Boston (R&D) and in the San Francisco Bay Area (Commercial Operations).

Requirements

Doctor of Pharmacy 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 a variety of projects at both the industry site and Northeastern

Responsibilities

Support preparation of INDs, CTAs, NDAs/BLAs, orphan drug applications, pediatric plans, briefing documents, and Health Authority responses; participate in FDA, EMA, and PMDA meetings.
Support development and maintenance of the Investigator’s Brochure, protocols, ICFs, and global product labeling, including CCDS, USPI, and EU SmPC.
Partner with Clinical Development, Drug Safety, CMC, and other functions to provide regulatory input and ensure alignment across development programs.
Review promotional and advertising materials for regulatory compliance and participate in cross-functional PRC/MLR processes, including digital and social media content.
Monitor evolving FDA/EMA/ICH requirements and competitive regulatory activity; support inspection readiness and process improvement initiatives.
Participate in academic seminars, research, teaching, conferences, and internal presentations while developing leadership, communication, and project management skills through mentorship.