[Hiring] Global Regulatory Affairs Postdoctoral Research Fellow @Northeastern University

Role Description

The 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.

Responsibilities

• Gain hands-on training in global drug development and regulatory strategy.
• Support submission of industry’s regulatory new drug applications (INDs, CTAs, NDAs/BLAs), labeling, and health authorities' interactions.
• Collaborate with cross-functional teams across Clinical, Safety, and CMC.
• Participate in 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.
• 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.
• Develop 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.

Additional Information

• Applicants should submit the following application materials by the priority deadline of October 31, 2026:
  • Curriculum vitae (CV), uploaded
  • Unofficial PharmD transcripts, uploaded
  • Cover letter, uploaded
• Three formal Letters of Recommendation (LORs) must be submitted directly by the letter writers no later than November 23, 2026.
• Each letter writer must include:
  • The candidate's full name
  • The fellowship program(s) to which the candidate is applying (e.g., Smith, John – Alnylam, GSK)
• Recommendations must be submitted directly by the recommender and cannot be submitted by the applicant.
• Address cover letter and letters of recommendation to:
  • J. Andrew Orr-Skirvin, PharmD, BCOP
  • Clinical Professor, Department of Pharmacy & Health Systems Sciences
  • Pharmaceutical Industry Fellowship Program Director
  • 360 Huntington Ave, 140 The Fenway R218
  • Boston, MA 02115
• 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.

Compensation

• Compensation Grade/Pay Type: 108S
• Expected Hiring Range: $60,315.00 - $85,192.50
• Starting salary will depend on several factors, which may include 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.

Benefits

• Northeastern has a comprehensive benefits package for benefit eligible employees, including:
  • Medical, vision, dental
  • Paid time off
  • Tuition assistance
  • Wellness & life
  • Retirement
  • Commuting & transportation
• Visit https://hr.northeastern.edu/benefits/ for more information.

Equal Opportunity Statement

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.