Dompe- Global Regulatory Affairs Postdoctoral Research Fellow

NU USA Northeastern University; Boston (MA); Remote; USD 60,000 - 85,000; Full time

Benefits offered by this job

Medical insurance

Tuition assistance

Paid time off

Retirement plan

Wellness program

Commuting & transportation

Job summary

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

Qualifications

• 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

Responsibilities

• 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

Skills

Communication skills

Time management

Leadership abilities

Independent work

Education

Doctor of Pharmacy (PharmD)

Job description

About the Opportunity

About the Opportunity 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.

About Dompé

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).

Responsibilities

• PharmD fellow will gain hands‑on training in global drug development and regulatory strategy. Over two years, the fellow will support submission of industry’s regulatory new drug applications (INDs, CTAs, NDAs/BLAs), labeling, and health authorities' interactions, while collaborating with cross functional teams across Clinical, Safety and CMC. The program also includes a 6‑month rotation in Commercial Regulatory Affairs, providing exposure to advertising, promotion, and labeling compliance.
• Regulatory Strategy & Submissions: 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.
• Labeling & Core Documentation: Support development and maintenance of the Investigator’s Brochure, protocols, ICFs, and global product labeling, including CCDS, USPI, and EU SmPC.
• Cross‑Functional Collaboration: Partner with Clinical Development, Drug Safety, CMC, and other functions to provide regulatory input and ensure alignment across development programs.
• Commercial Regulatory: Review promotional and advertising materials for regulatory compliance and participate in cross‑functional PRC/MLR processes, including digital and social media content.
• Compliance & Regulatory Intelligence: Monitor evolving FDA/EMA/ICH requirements and competitive regulatory activity; support inspection readiness and process improvement initiatives.
• Professional Development & Leadership: Participate in academic seminars, research, teaching, conferences, and internal presentations while developing leadership, communication, and project management skills through mentorship.

Qualifications

• 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

Compensation

Compensation Grade/Pay Type: 108S Expected Hiring Range: $60,315.00 - $85,192.50 With the pay range(s) shown above, the starting salary will depend on several factors, which may include your education, experience, location, knowledge and expertise, and skills as well as a pay comparison to similarly‑situated employees already in the role. Salary ranges are reviewed regularly and are subject to change.

Eligibility and Authorizations

Northeastern University will not provide H-1B, TN, O-1, E-3, or any other type of employment visa sponsorship for the successful applicant to this position, now or in the future. STEM OPT is not compatible for this position. The successful applicant must be able to maintain valid work authorization in the United States throughout the entire appointment without Northeastern University's sponsorship for a visa.

Position Type

Research

Hiring Process

Northeastern University considers factors such as candidate work experience, education and skills when extending an offer.

Benefits

Northeastern has a comprehensive benefits package for benefit eligible employees. This includes medical, vision, dental, paid time off, tuition assistance, wellness & life, retirement- as well as commuting & transportation. Visit https://hr.northeastern.edu/benefits/ for more information.

Equal Opportunity & Diversity

All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, religion, color, national origin, age, sex, sexual orientation, disability status, or any other characteristic protected by applicable law.

Company Description

Founded in 1898, Northeastern is a global research university and the recognized leader in experiential lifelong learning. Our approach of integrating real‑world experience with education, research, and innovation empowers our students, faculty, alumni, and partners to create worldwide impact. Our global university system provides our community and academic, government, and industry partners with unique opportunities to think locally and act globally. The system—including 14 campuses across the U.S., U.K., and Canada, 300,000-plus alumni, and 3,000 partners worldwide—serves as a platform for scaling ideas, talent, and solutions. The university’s residential campuses for undergraduate and graduate degrees are located in Boston, London, and Oakland, California. Our research and graduate campuses are in the Massachusetts communities of Burlington and Nahant; Arlington, Virginia; Charlotte, North Carolina; Miami; Portland, Maine; Seattle; Silicon Valley, California; Toronto; and Vancouver. Northeastern’s personalized, experiential undergraduate and graduate programs lead to degrees through the doctorate in 10 colleges and schools across our campuses. Learning emphasizes the intersection of data, technology, and human literacies, uniquely preparing graduates for careers of the future and lives of fulfillment and accomplishment. Our research enterprise, with an R1 Carnegie classification, is solutions oriented and spans the world. Our faculty scholars and students work in teams that cross not just disciplines, but also sectors—aligned around solving today’s highly interconnected global challenges and focused on transformative impact for humankind.