Dompe-Postdoctoral Research Fellow, Global Regulatory Affairs

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, Dompe is offering a two-year Global Regulatory Affairs fellowship, based Remote with the option to relocate to San Mateo, CA .

About Dompe

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 900 employees. The US headquarters of Dompé are based in Boston (R&D) and in the San Francisco Bay Area (Commercial Operations).

Responsibilities

The 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. Conducted in partnership with Northeastern University, the fellowship blends industry experience and academic engagement to prepare fellows for impactful careers in Regulatory Affairs.

Regulatory Strategy and submissions 

• Contribute to the preparation and review of regulatory submissions (INDs, CTAs, NDAs/BLAs, orphan drug applications, pediatric study plans…) 

• Support drafting of regulatory briefing documents and responses to Health Authorities 

• Participate in health authority meetings under mentorship (FDA, EMA, PMDA, etc.). 

Labeling & Core Documentation 

• Assist in the development and maintenance of core regulatory documents (Investigator’s Brochure, study protocols, Informed Consent Forms, product labeling). 

• Support global labeling activities, including updates to Company Core Data Sheet (CCDS), US Prescribing Information, and EU SmPC. 

Cross-Functional Collaboration 

• Work closely with Clinical Development, Drug Safety, CMC teams to ensure regulatory alignment across programs. 

• Participate in project team meetings and contribute a regulatory perspective to development strategies. 

Commercial Regulatory Rotation (6 months) 

• Review advertising and promotional materials to ensure compliance with FDA and global regulations. 

• Collaboration with cross-functional Promotional Review Committees (PRC/MLR). 

• Gain experience with regulatory requirements for promotional labeling and digital/social media campaigns. 

Compliance & Regulatory Intelligence 

• Conduct regulatory intelligence to track evolving FDA/EMA/ICH guidance and competitor activity. 

• Support inspection readiness and contribute to internal process improvements. 

Professional Development & Academic Engagement 

• Engage in seminars, research, and teaching opportunities through Northeastern University. 

• Present fellowship learnings at professional conferences or internal forums. 

• Develop leadership, communication, and project management skills under the mentorship of experienced regulatory leaders. 

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

• Understanding of drug dev